Trial Outcomes & Findings for A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease (NCT NCT01135511)
NCT ID: NCT01135511
Last Updated: 2013-05-07
Results Overview
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
285 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2013-05-07
Participant Flow
In this study, during the 2-week run-in period, enrolled participants were administered artificial tears 4 times daily after signing informed consent.
Participant milestones
| Measure |
CP-690,550 Eye Drops Vehicle Group in Japan
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
41
|
40
|
39
|
21
|
19
|
21
|
21
|
|
Overall Study
COMPLETED
|
41
|
39
|
33
|
37
|
38
|
20
|
18
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
8
|
3
|
1
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
CP-690,550 Eye Drops Vehicle Group in Japan
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
could not visit the clinic
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
noncompliance with study drug taken
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
n=19 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Between 18 and 44 years
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
11 participants
n=21 Participants
|
5 participants
n=8 Participants
|
8 participants
n=8 Participants
|
7 participants
n=24 Participants
|
3 participants
n=42 Participants
|
84 participants
n=42 Participants
|
|
Age, Customized
Between 45 and 64 years
|
9 participants
n=5 Participants
|
14 participants
n=7 Participants
|
12 participants
n=5 Participants
|
16 participants
n=4 Participants
|
14 participants
n=21 Participants
|
10 participants
n=8 Participants
|
8 participants
n=8 Participants
|
13 participants
n=24 Participants
|
10 participants
n=42 Participants
|
106 participants
n=42 Participants
|
|
Age, Customized
>=65 years
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
13 participants
n=4 Participants
|
14 participants
n=21 Participants
|
6 participants
n=8 Participants
|
3 participants
n=8 Participants
|
1 participants
n=24 Participants
|
8 participants
n=42 Participants
|
95 participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
250 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
n=19 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
|
-3.2 Units on a scale
Standard Deviation 2.4
|
-3.0 Units on a scale
Standard Deviation 2.1
|
-3.0 Units on a scale
Standard Deviation 2.8
|
-3.0 Units on a scale
Standard Deviation 2.5
|
-3.1 Units on a scale
Standard Deviation 2.6
|
-2.4 Units on a scale
Standard Deviation 2.4
|
-3.0 Units on a scale
Standard Deviation 2.7
|
-2.8 Units on a scale
Standard Deviation 1.9
|
-2.2 Units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2 and 4Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment.
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in Corneal Staining Scores for Study Eye From Baseline
Week 1
|
-2.0 Units on a scale
Standard Deviation 2.0
|
-2.1 Units on a scale
Standard Deviation 1.9
|
-1.9 Units on a scale
Standard Deviation 2.1
|
-1.9 Units on a scale
Standard Deviation 2.1
|
-1.6 Units on a scale
Standard Deviation 2.0
|
—
|
—
|
—
|
—
|
|
Changes in Corneal Staining Scores for Study Eye From Baseline
Week 2
|
-2.8 Units on a scale
Standard Deviation 2.1
|
-2.4 Units on a scale
Standard Deviation 1.8
|
-2.4 Units on a scale
Standard Deviation 2.0
|
-3.2 Units on a scale
Standard Deviation 1.8
|
-3.0 Units on a scale
Standard Deviation 2.0
|
—
|
—
|
—
|
—
|
|
Changes in Corneal Staining Scores for Study Eye From Baseline
Week 4
|
-2.6 Units on a scale
Standard Deviation 2.1
|
-2.7 Units on a scale
Standard Deviation 2.0
|
-3.0 Units on a scale
Standard Deviation 2.7
|
-3.2 Units on a scale
Standard Deviation 2.4
|
-3.3 Units on a scale
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.
Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Week 1 (n=41, 41, 40, 40, 39)
|
0 Percentage of participants
|
4.9 Percentage of participants
|
2.4 Percentage of participants
|
5.0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Week 2 (n=40, 41, 39, 40, 39)
|
2.6 Percentage of participants
|
2.5 Percentage of participants
|
2.4 Percentage of participants
|
5.1 Percentage of participants
|
7.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Week 4 (n=41, 40, 35, 40, 38)
|
2.6 Percentage of participants
|
12.2 Percentage of participants
|
5.0 Percentage of participants
|
8.6 Percentage of participants
|
7.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
0 Percentage of participants
|
12.2 Percentage of participants
|
4.9 Percentage of participants
|
7.5 Percentage of participants
|
7.5 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 \[Absent\] to 5 \[Severe\]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Week 1 (n=41, 41, 40, 40, 39)
|
-0.6 Units on a scale
Standard Deviation 1.7
|
-0.8 Units on a scale
Standard Deviation 1.9
|
-0.7 Units on a scale
Standard Deviation 1.8
|
-0.6 Units on a scale
Standard Deviation 1.3
|
-1.1 Units on a scale
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
|
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Week 2 (n=40, 41, 39, 40, 39)
|
-1.0 Units on a scale
Standard Deviation 2.1
|
-1.0 Units on a scale
Standard Deviation 2.2
|
-0.8 Units on a scale
Standard Deviation 2.0
|
-0.7 Units on a scale
Standard Deviation 1.5
|
-1.7 Units on a scale
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
|
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Week 4 (n=41, 40, 35, 40, 38)
|
-1.1 Units on a scale
Standard Deviation 2.2
|
-1.2 Units on a scale
Standard Deviation 2.2
|
-1.0 Units on a scale
Standard Deviation 1.7
|
-0.8 Units on a scale
Standard Deviation 1.5
|
-2.0 Units on a scale
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
|
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
-0.9 Units on a scale
Standard Deviation 1.8
|
-1.0 Units on a scale
Standard Deviation 2.3
|
-1.1 Units on a scale
Standard Deviation 2.1
|
-0.9 Units on a scale
Standard Deviation 1.4
|
-2.0 Units on a scale
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
0.76 Seconds
Standard Deviation 1.38
|
-0.06 Seconds
Standard Deviation 1.13
|
-0.25 Seconds
Standard Deviation 2.17
|
0.27 Seconds
Standard Deviation 0.77
|
1.00 Seconds
Standard Deviation 3.56
|
—
|
—
|
—
|
—
|
|
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
Week 1 (n=41, 41, 40, 40, 39)
|
0.43 Seconds
Standard Deviation 3.22
|
0.04 Seconds
Standard Deviation 0.83
|
0.43 Seconds
Standard Deviation 3.61
|
0.19 Seconds
Standard Deviation 0.76
|
0.22 Seconds
Standard Deviation 1.95
|
—
|
—
|
—
|
—
|
|
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
Week 2 (n=40, 41, 39, 40, 39)
|
1.72 Seconds
Standard Deviation 8.53
|
0.09 Seconds
Standard Deviation 0.95
|
-0.31 Seconds
Standard Deviation 2.84
|
0.26 Seconds
Standard Deviation 0.84
|
0.04 Seconds
Standard Deviation 1.54
|
—
|
—
|
—
|
—
|
|
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
Week 4 (n=41, 40, 35, 40, 38)
|
0.53 Seconds
Standard Deviation 1.42
|
-0.01 Seconds
Standard Deviation 0.92
|
0.20 Seconds
Standard Deviation 3.61
|
0.31 Seconds
Standard Deviation 0.62
|
0.46 Seconds
Standard Deviation 1.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
Week 1 (n=41, 41, 40, 40, 39)
|
0.71 Millimeters
Standard Deviation 3.99
|
0.78 Millimeters
Standard Deviation 6.07
|
0.34 Millimeters
Standard Deviation 3.10
|
0.01 Millimeters
Standard Deviation 2.16
|
0.08 Millimeters
Standard Deviation 3.01
|
—
|
—
|
—
|
—
|
|
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
Week 2 (n=40, 41, 39, 40, 39)
|
1.04 Millimeters
Standard Deviation 4.53
|
0.28 Millimeters
Standard Deviation 2.77
|
0.51 Millimeters
Standard Deviation 3.49
|
0.28 Millimeters
Standard Deviation 2.26
|
0.93 Millimeters
Standard Deviation 3.56
|
—
|
—
|
—
|
—
|
|
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
Week 4 (n=41, 40, 35, 40, 38)
|
0.64 Millimeters
Standard Deviation 3.38
|
0.30 Millimeters
Standard Deviation 3.39
|
0.49 Millimeters
Standard Deviation 2.54
|
0.13 Millimeters
Standard Deviation 2.28
|
1.13 Millimeters
Standard Deviation 4.23
|
—
|
—
|
—
|
—
|
|
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
1.53 Millimeters
Standard Deviation 5.32
|
0.91 Millimeters
Standard Deviation 5.43
|
0.10 Millimeters
Standard Deviation 2.57
|
0.74 Millimeters
Standard Deviation 2.46
|
0.26 Millimeters
Standard Deviation 2.93
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
Week 1 (n=41, 41, 40, 40, 39)
|
7.7 Percentage of participants
|
7.3 Percentage of participants
|
4.9 Percentage of participants
|
0 Percentage of participants
|
2.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
Week 2 (n=40, 41, 39, 40, 39)
|
10.3 Percentage of participants
|
2.5 Percentage of participants
|
4.9 Percentage of participants
|
2.6 Percentage of participants
|
7.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
Week 4 (n=41, 40, 35, 40, 38)
|
5.3 Percentage of participants
|
7.3 Percentage of participants
|
5.0 Percentage of participants
|
2.9 Percentage of participants
|
7.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
12.8 Percentage of participants
|
9.8 Percentage of participants
|
4.9 Percentage of participants
|
2.5 Percentage of participants
|
5.0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
Week 1 (n=41, 41, 40, 40, 39)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
Week 2 (n=40, 41, 39, 40, 39)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
Week 4 (n=41, 40, 35, 40, 38)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
-4.22 Units on a scale
Standard Deviation 9.53
|
-5.09 Units on a scale
Standard Deviation 7.74
|
-4.98 Units on a scale
Standard Deviation 7.67
|
-3.90 Units on a scale
Standard Deviation 9.30
|
-6.87 Units on a scale
Standard Deviation 8.59
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
Week 1 (n=41, 41, 40, 40, 39)
|
-3.14 Units on a scale
Standard Deviation 7.88
|
-1.94 Units on a scale
Standard Deviation 5.20
|
-2.00 Units on a scale
Standard Deviation 6.22
|
-2.13 Units on a scale
Standard Deviation 7.92
|
-4.17 Units on a scale
Standard Deviation 6.86
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
Week 2 (n=40, 41, 40, 40, 39)
|
-3.40 Units on a scale
Standard Deviation 6.12
|
-4.16 Units on a scale
Standard Deviation 9.00
|
-4.76 Units on a scale
Standard Deviation 7.63
|
-3.80 Units on a scale
Standard Deviation 8.77
|
-5.88 Units on a scale
Standard Deviation 6.98
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
Week 4 (n=41, 40, 35, 40, 38)
|
-3.58 Units on a scale
Standard Deviation 9.85
|
-3.27 Units on a scale
Standard Deviation 6.95
|
-4.20 Units on a scale
Standard Deviation 7.08
|
-5.77 Units on a scale
Standard Deviation 9.71
|
-5.74 Units on a scale
Standard Deviation 7.26
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
Week 1 (n=41, 41, 40, 40, 39)
|
16 Participants
|
17 Participants
|
15 Participants
|
13 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
Week 2 (n=40, 41, 40, 40, 39)
|
20 Participants
|
19 Participants
|
21 Participants
|
19 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
Week 4 (n=41, 40, 35, 40, 38)
|
16 Participants
|
23 Participants
|
23 Participants
|
21 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
16 Participants
|
25 Participants
|
26 Participants
|
22 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
Week 1 (n=41, 41, 40, 40, 39)
|
-2.99 Units on a scale
Standard Deviation 10.27
|
-0.43 Units on a scale
Standard Deviation 12.33
|
-3.87 Units on a scale
Standard Deviation 12.42
|
-0.67 Units on a scale
Standard Deviation 12.68
|
-5.00 Units on a scale
Standard Deviation 9.13
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
Week 2 (n=40, 41, 40, 40, 39)
|
-2.89 Units on a scale
Standard Deviation 11.34
|
-4.09 Units on a scale
Standard Deviation 13.73
|
-7.04 Units on a scale
Standard Deviation 12.98
|
-3.13 Units on a scale
Standard Deviation 14.45
|
-6.77 Units on a scale
Standard Deviation 11.28
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
Week 4 (n=41, 40, 35, 40, 38)
|
-2.56 Units on a scale
Standard Deviation 12.69
|
-3.18 Units on a scale
Standard Deviation 13.77
|
-5.99 Units on a scale
Standard Deviation 15.78
|
-4.48 Units on a scale
Standard Deviation 13.92
|
-5.11 Units on a scale
Standard Deviation 14.03
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
-2.68 Units on a scale
Standard Deviation 15.10
|
-3.88 Units on a scale
Standard Deviation 14.92
|
-7.07 Units on a scale
Standard Deviation 17.88
|
-0.37 Units on a scale
Standard Deviation 16.77
|
-5.89 Units on a scale
Standard Deviation 14.98
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[the none of time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 1 to 3 answered) × 100\]/\[(total number of questions 1 to 3 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
Week 1 (n=41, 41, 40, 40, 39)
|
-2.56 Units on a scale
Standard Deviation 14.70
|
-0.81 Units on a scale
Standard Deviation 15.90
|
-4.07 Units on a scale
Standard Deviation 13.83
|
-3.96 Units on a scale
Standard Deviation 13.74
|
-5.00 Units on a scale
Standard Deviation 12.77
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
Week 2 (n=40, 41, 40, 40, 39)
|
-3.63 Units on a scale
Standard Deviation 13.49
|
-4.17 Units on a scale
Standard Deviation 19.61
|
-8.74 Units on a scale
Standard Deviation 18.06
|
-3.75 Units on a scale
Standard Deviation 14.24
|
-7.92 Units on a scale
Standard Deviation 16.01
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
Week 4 (n=41, 40, 35, 40, 38)
|
-1.97 Units on a scale
Standard Deviation 15.43
|
-3.05 Units on a scale
Standard Deviation 18.89
|
-7.50 Units on a scale
Standard Deviation 19.59
|
-6.19 Units on a scale
Standard Deviation 14.05
|
-5.42 Units on a scale
Standard Deviation 17.56
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
-0.21 Units on a scale
Standard Deviation 15.59
|
-3.86 Units on a scale
Standard Deviation 19.01
|
-7.72 Units on a scale
Standard Deviation 21.20
|
-2.29 Units on a scale
Standard Deviation 17.29
|
-6.04 Units on a scale
Standard Deviation 18.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 4 to 9 answered) × 100\]/\[(total number of questions 4 to 9 answered) × 4\]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
Week 1 (n=41, 41, 40, 40, 39)
|
-3.33 Units on a scale
Standard Deviation 13.41
|
-0.36 Units on a scale
Standard Deviation 18.75
|
-4.71 Units on a scale
Standard Deviation 14.31
|
0.40 Units on a scale
Standard Deviation 17.35
|
-6.55 Units on a scale
Standard Deviation 12.20
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
Week 2 (n=40, 41, 40, 40, 39)
|
-2.57 Units on a scale
Standard Deviation 14.48
|
-2.61 Units on a scale
Standard Deviation 16.88
|
-5.83 Units on a scale
Standard Deviation 15.52
|
-2.29 Units on a scale
Standard Deviation 20.91
|
-7.06 Units on a scale
Standard Deviation 11.87
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
Week 4 (n=41, 40, 35, 40, 38)
|
-2.69 Units on a scale
Standard Deviation 15.35
|
-1.70 Units on a scale
Standard Deviation 16.73
|
-6.52 Units on a scale
Standard Deviation 15.25
|
-4.74 Units on a scale
Standard Deviation 17.82
|
-4.29 Units on a scale
Standard Deviation 14.04
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
-3.81 Units on a scale
Standard Deviation 17.46
|
-2.56 Units on a scale
Standard Deviation 19.45
|
-8.29 Units on a scale
Standard Deviation 16.61
|
-2.07 Units on a scale
Standard Deviation 18.71
|
-4.75 Units on a scale
Standard Deviation 12.49
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 10 to 12 answered) × 100\]/\[(total number of questions 10 to 12 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
Week 1 (n=38, 37, 40, 39, 35)
|
-4.88 Units on a scale
Standard Deviation 20.32
|
1.21 Units on a scale
Standard Deviation 22.11
|
-4.28 Units on a scale
Standard Deviation 23.66
|
0.31 Units on a scale
Standard Deviation 22.20
|
-3.53 Units on a scale
Standard Deviation 15.52
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
Week 2 (n=37, 37, 39, 37, 37)
|
-4.28 Units on a scale
Standard Deviation 21.48
|
-6.53 Units on a scale
Standard Deviation 20.43
|
-7.21 Units on a scale
Standard Deviation 25.43
|
-6.20 Units on a scale
Standard Deviation 22.25
|
-8.56 Units on a scale
Standard Deviation 18.66
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
Week 4 (n=38, 37, 35, 37, 36)
|
-4.17 Units on a scale
Standard Deviation 23.44
|
-6.14 Units on a scale
Standard Deviation 23.72
|
-3.15 Units on a scale
Standard Deviation 30.23
|
-2.14 Units on a scale
Standard Deviation 24.88
|
-9.57 Units on a scale
Standard Deviation 22.78
|
—
|
—
|
—
|
—
|
|
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
Week 8 (n=38, 37, 40, 39, 38, LOCF)
|
-4.82 Units on a scale
Standard Deviation 24.46
|
-7.13 Units on a scale
Standard Deviation 22.92
|
-4.05 Units on a scale
Standard Deviation 34.11
|
3.02 Units on a scale
Standard Deviation 31.76
|
-8.44 Units on a scale
Standard Deviation 27.83
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 4 and 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
Week 1 (n=41, 41, 40, 40, 39)
|
20.5 Percentage of participants
|
14.6 Percentage of participants
|
24.4 Percentage of participants
|
12.5 Percentage of participants
|
22.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
Week 2 (n=40, 41, 40, 40, 39)
|
20.5 Percentage of participants
|
32.5 Percentage of participants
|
34.1 Percentage of participants
|
27.5 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
Week 4 (n=41, 40, 35, 40, 38)
|
18.4 Percentage of participants
|
34.1 Percentage of participants
|
37.5 Percentage of participants
|
25.7 Percentage of participants
|
35.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
Week 8 (n=41, 41, 40, 40, 39, LOCF)
|
20.5 Percentage of participants
|
34.1 Percentage of participants
|
41.5 Percentage of participants
|
22.5 Percentage of participants
|
35.0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment.
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
|
1 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment.
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
|
7 Participants
|
8 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat population: Participants who received at least 1 dose of study treatment.
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
|
28 Participants
|
31 Participants
|
29 Participants
|
30 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Safety analysis set: Participants who received at least 1 dose of study treatment.
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
n=19 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Ocular Adverse Events (AEs)by Severity
Mild
|
2 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Ocular Adverse Events (AEs)by Severity
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Ocular Adverse Events (AEs)by Severity
Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Safety analysis set: Participants who received at least 1 dose of study treatment.
Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
n=19 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Mild
|
8 Participants
|
7 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Safety analysis set: Participants who received at least 1 dose of study treatment.
Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
n=19 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
n=21 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Severe for blurring of vision
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Moderate for burning sensation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
None for burning sensation
|
34 Participants
|
26 Participants
|
22 Participants
|
26 Participants
|
27 Participants
|
7 Participants
|
7 Participants
|
11 Participants
|
9 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Minor for burning sensation
|
4 Participants
|
15 Participants
|
19 Participants
|
14 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
None for blurring of vision
|
36 Participants
|
32 Participants
|
33 Participants
|
32 Participants
|
32 Participants
|
11 Participants
|
11 Participants
|
15 Participants
|
13 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Minor for blurring of vision
|
3 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Moderate for blurring of vision
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Severe for burning sensation
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
None for ocular discomfort
|
29 Participants
|
30 Participants
|
29 Participants
|
30 Participants
|
31 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Minor for ocular discomfort
|
8 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
11 Participants
|
6 Participants
|
8 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Moderate for ocular discomfort
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Severe for ocular discomfort
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
None for pain
|
34 Participants
|
28 Participants
|
30 Participants
|
34 Participants
|
32 Participants
|
12 Participants
|
9 Participants
|
12 Participants
|
9 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Minor for pain
|
3 Participants
|
13 Participants
|
11 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Moderate for pain
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Severe for pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
None for tearing
|
36 Participants
|
40 Participants
|
38 Participants
|
39 Participants
|
37 Participants
|
15 Participants
|
15 Participants
|
18 Participants
|
19 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Minor for tearing
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Moderate for tearing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Severe for tearing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.
The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=13 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=5 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=10 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=12 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye
Week 4 (n=7, 4, 9, 12, 8)
|
-1908.6 Antibodies bound per cell
Standard Deviation 11259.4
|
1570.4 Antibodies bound per cell
Standard Deviation 8698.5
|
-13899.5 Antibodies bound per cell
Standard Deviation 13383.8
|
5394.3 Antibodies bound per cell
Standard Deviation 10641.9
|
1573.8 Antibodies bound per cell
Standard Deviation 10087.5
|
—
|
—
|
—
|
—
|
|
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye
Week 8 (n=6, 4, 6, 11, 10)
|
1148.5 Antibodies bound per cell
Standard Deviation 12129.6
|
-1496.5 Antibodies bound per cell
Standard Deviation 10426.5
|
-8326.3 Antibodies bound per cell
Standard Deviation 11164.6
|
56.0 Antibodies bound per cell
Standard Deviation 5308.4
|
3431.9 Antibodies bound per cell
Standard Deviation 16532.5
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.
Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=13 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=5 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=10 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=12 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye
Week 4 (n=7, 4, 9, 12, 8)
|
18.30 Percentage of positive cells
Standard Deviation 30.40
|
-10.27 Percentage of positive cells
Standard Deviation 20.73
|
-0.87 Percentage of positive cells
Standard Deviation 18.24
|
11.51 Percentage of positive cells
Standard Deviation 18.74
|
-6.83 Percentage of positive cells
Standard Deviation 28.64
|
—
|
—
|
—
|
—
|
|
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye
Week 8 (n=6, 4, 6, 11, 10)
|
11.74 Percentage of positive cells
Standard Deviation 24.84
|
-6.77 Percentage of positive cells
Standard Deviation 18.19
|
6.65 Percentage of positive cells
Standard Deviation 25.65
|
5.17 Percentage of positive cells
Standard Deviation 24.73
|
-1.05 Percentage of positive cells
Standard Deviation 35.75
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3
Week 4 (n=4, 5, 2, 4, 3)
|
58.500 ng/mL
Standard Deviation 59.729
|
-30.675 ng/mL
Standard Deviation 78.363
|
-38.540 ng/mL
Standard Deviation 93.153
|
-153.500 ng/mL
Standard Deviation 164.756
|
-6384.063 ng/mL
Standard Deviation 12606.637
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3
Week 8 (n=4, 6, 2, 5, 3)
|
-1.300 ng/mL
Standard Deviation 1.752
|
-39.250 ng/mL
Standard Deviation 786.061
|
-5.167 ng/mL
Standard Deviation 33.983
|
-70.800 ng/mL
Standard Deviation 16.688
|
-5102.010 ng/mL
Standard Deviation 11352.752
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18
Week 4 (n=4, 5, 2, 4, 3)
|
22.5 pg/mL
Standard Deviation 57.1
|
247.5 pg/mL
Standard Deviation 374.7
|
-73.0 pg/mL
Standard Deviation 57.6
|
146.0 pg/mL
Standard Deviation 206.5
|
-154.6 pg/mL
Standard Deviation 287.3
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18
Week 8 (n=4, 6, 2, 5, 3)
|
51.2 pg/mL
Standard Deviation 27.0
|
-81.3 pg/mL
Standard Deviation 110.7
|
-6.0 pg/mL
Standard Deviation 186.1
|
100.0 pg/mL
Standard Deviation 43.8
|
18.0 pg/mL
Standard Deviation 210.9
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6
Week 4 (n=4, 5, 2, 4, 3)
|
16.33 pg/mL
Standard Deviation 34.70
|
76.00 pg/mL
Standard Deviation 140.92
|
-36.80 pg/mL
Standard Deviation 48.75
|
22.50 pg/mL
Standard Deviation 21.92
|
-19.70 pg/mL
Standard Deviation 126.34
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6
Week 8 (n=4, 6, 2, 5, 3)
|
12.00 pg/mL
Standard Deviation 14.00
|
-11.00 pg/mL
Standard Deviation 23.35
|
4.00 pg/mL
Standard Deviation 25.49
|
139.00 pg/mL
Standard Deviation 192.33
|
25.80 pg/mL
Standard Deviation 141.39
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7
Week 4 (n=4, 5, 2, 4, 3)
|
10.0 pg/mL
Standard Deviation 50.7
|
35.8 pg/mL
Standard Deviation 51.6
|
-6.8 pg/mL
Standard Deviation 38.8
|
28.0 pg/mL
Standard Deviation 22.6
|
3.5 pg/mL
Standard Deviation 73.6
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7
Week 8 (n=4, 6, 2, 5, 3)
|
25.0 pg/mL
Standard Deviation 16.5
|
14.3 pg/mL
Standard Deviation 16.7
|
19.5 pg/mL
Standard Deviation 30.9
|
-15.0 pg/mL
Standard Deviation 8.5
|
-16.4 pg/mL
Standard Deviation 28.6
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8
Week 4 (n=4, 5, 2, 4, 3)
|
564.3 pg/mL
Standard Deviation 1171.8
|
365.0 pg/mL
Standard Deviation 348.2
|
-18.8 pg/mL
Standard Deviation 739.1
|
-7.0 pg/mL
Standard Deviation 470.9
|
-1057.3 pg/mL
Standard Deviation 1954.2
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8
Week 8 (n=4, 6, 2, 5, 3)
|
305.7 pg/mL
Standard Deviation 361.9
|
-2486.3 pg/mL
Standard Deviation 4656.3
|
-367.8 pg/mL
Standard Deviation 961.9
|
-112.5 pg/mL
Standard Deviation 484.4
|
-471.6 pg/mL
Standard Deviation 2378.4
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1
Week 4 (n=4, 5, 2, 4, 3)
|
26.7 pg/mL
Standard Deviation 63.1
|
-168.5 pg/mL
Standard Deviation 265.3
|
-438.8 pg/mL
Standard Deviation 962.4
|
24.5 pg/mL
Standard Deviation 79.9
|
-468.0 pg/mL
Standard Deviation 390.6
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1
Week 8 (n=4, 6, 2, 5, 3)
|
-14.3 pg/mL
Standard Deviation 33.9
|
-179.3 pg/mL
Standard Deviation 144.1
|
-289.7 pg/mL
Standard Deviation 1205.3
|
-169.5 pg/mL
Standard Deviation 217.1
|
28.2 pg/mL
Standard Deviation 431.0
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)
Week 4 (n=4, 5, 2, 4, 3)
|
3.7 pg/mL
Standard Deviation 22.7
|
-5.0 pg/mL
Standard Deviation 16.1
|
-5.4 pg/mL
Standard Deviation 17.0
|
27.0 pg/mL
Standard Deviation 14.1
|
-17.0 pg/mL
Standard Deviation 24.9
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)
Week 8 (n=4, 6, 2, 5, 3)
|
31.7 pg/mL
Standard Deviation 23.6
|
17.5 pg/mL
Standard Deviation 21.7
|
15.8 pg/mL
Standard Deviation 57.9
|
0.0 pg/mL
Standard Deviation 0.0
|
1.6 pg/mL
Standard Deviation 38.4
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta
Week 4 (n=4, 5, 2, 4, 3)
|
6.03 pg/mL
Standard Deviation 8.54
|
-0.05 pg/mL
Standard Deviation 1.60
|
-1.42 pg/mL
Standard Deviation 5.22
|
2.75 pg/mL
Standard Deviation 0.35
|
-4.93 pg/mL
Standard Deviation 10.29
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta
Week 8 (n=4, 6, 2, 5, 3)
|
2.03 pg/mL
Standard Deviation 0.15
|
-0.70 pg/mL
Standard Deviation 4.97
|
-0.42 pg/mL
Standard Deviation 5.84
|
6.00 pg/mL
Standard Deviation 8.49
|
-2.14 pg/mL
Standard Deviation 7.88
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist
Week 4 (n=3, 5, 2, 4, 3)
|
15600.0 pg/mL
Standard Deviation 156124.6
|
76500.0 pg/mL
Standard Deviation 363953.6
|
-172800.0 pg/mL
Standard Deviation 256165.4
|
269500.0 pg/mL
Standard Deviation 498510.3
|
-370575.0 pg/mL
Standard Deviation 647507.1
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist
Week 8 (n=4, 6, 2, 5, 2)
|
397550.0 pg/mL
Standard Deviation 621476.1
|
-256000.0 pg/mL
Standard Deviation 451986.0
|
153833.3 pg/mL
Standard Deviation 317150.7
|
200000.0 pg/mL
Standard Deviation 144249.8
|
-268260.0 pg/mL
Standard Deviation 546901.3
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23
Week 4 (n=4, 5, 2, 4, 3)
|
2.73 ng/mL
Standard Deviation 3.04
|
3.15 ng/mL
Standard Deviation 6.14
|
-13.80 ng/mL
Standard Deviation 22.14
|
8.00 ng/mL
Standard Deviation 21.21
|
-7.13 ng/mL
Standard Deviation 19.21
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23
Week 8 (n=4, 6, 2, 5, 3)
|
0.00 ng/mL
Standard Deviation 0.00
|
-6.78 ng/mL
Standard Deviation 18.62
|
3.60 ng/mL
Standard Deviation 16.65
|
-4.00 ng/mL
Standard Deviation 9.90
|
0.60 ng/mL
Standard Deviation 6.02
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3
Week 4 (n=4, 5, 2, 4, 3)
|
0.957 ng/mL
Standard Deviation 1.202
|
2.675 ng/mL
Standard Deviation 5.952
|
-1.948 ng/mL
Standard Deviation 3.682
|
-0.470 ng/mL
Standard Deviation 1.598
|
-24.833 ng/mL
Standard Deviation 48.019
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3
Week 8 (n=4, 6, 2, 5, 3)
|
0.203 ng/mL
Standard Deviation 0.313
|
21.205 ng/mL
Standard Deviation 42.696
|
-0.517 ng/mL
Standard Deviation 3.527
|
-0.650 ng/mL
Standard Deviation 0.919
|
-14.476 ng/mL
Standard Deviation 31.070
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9
Week 4 (n=4, 5, 2, 4, 3)
|
35.0 ng/mL
Standard Deviation 60.6
|
22.3 ng/mL
Standard Deviation 35.8
|
-13.2 ng/mL
Standard Deviation 29.5
|
8.5 ng/mL
Standard Deviation 12.0
|
-88.3 ng/mL
Standard Deviation 120.8
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9
Week 8 (n=4, 6, 2, 5, 3)
|
26.7 ng/mL
Standard Deviation 69.0
|
0.0 ng/mL
Standard Deviation 0.0
|
57.0 ng/mL
Standard Deviation 90.1
|
37.5 ng/mL
Standard Deviation 53.0
|
-41.2 ng/mL
Standard Deviation 46.7
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor
Week 4 (n=4, 5, 2, 4, 3)
|
546.7 pg/mL
Standard Deviation 546.4
|
152.5 pg/mL
Standard Deviation 1620.5
|
-942.0 pg/mL
Standard Deviation 2466.2
|
840.0 pg/mL
Standard Deviation 735.4
|
-1486.5 pg/mL
Standard Deviation 4486.5
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor
Week 8 (n=4, 6, 2, 5, 3)
|
-699.3 pg/mL
Standard Deviation 1094.8
|
-1812.5 pg/mL
Standard Deviation 1477.6
|
790.0 pg/mL
Standard Deviation 1639.2
|
-910.0 pg/mL
Standard Deviation 2588.0
|
734.0 pg/mL
Standard Deviation 3267.6
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin
Week 4 (n=4, 5, 2, 4, 3)
|
5400.0 ng/mL
Standard Deviation 3104.5
|
-1115.0 ng/mL
Standard Deviation 3226.2
|
-4054.0 ng/mL
Standard Deviation 8558.2
|
1535.0 ng/mL
Standard Deviation 2170.8
|
-628.5 ng/mL
Standard Deviation 5314.7
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin
Week 8 (n=4, 6, 2, 5, 3)
|
2246.7 ng/mL
Standard Deviation 2329.9
|
-2902.5 ng/mL
Standard Deviation 4534.4
|
505.0 ng/mL
Standard Deviation 2977.2
|
-1375.0 ng/mL
Standard Deviation 1944.5
|
1220.8 ng/mL
Standard Deviation 4111.8
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A
Week 4 (n=4, 5, 2, 4, 3)
|
1.60 pg/mL
Standard Deviation 1.44
|
1.98 pg/mL
Standard Deviation 5.47
|
-2.08 pg/mL
Standard Deviation 4.28
|
1.95 pg/mL
Standard Deviation 2.76
|
-4.30 pg/mL
Standard Deviation 9.40
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A
Week 8 (n=4, 6, 2, 5, 3)
|
3.93 pg/mL
Standard Deviation 4.61
|
-1.18 pg/mL
Standard Deviation 1.39
|
0.88 pg/mL
Standard Deviation 4.75
|
0.00 pg/mL
Standard Deviation 0.00
|
-3.58 pg/mL
Standard Deviation 8.01
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)
Week 4 (n=3, 5, 2, 4, 3)
|
15103.3 pg/mL
Standard Deviation 56584.3
|
-1196.7 pg/mL
Standard Deviation 3885.1
|
-7224.0 pg/mL
Standard Deviation 27315.6
|
14545.0 pg/mL
Standard Deviation 24967.9
|
-11622.5 pg/mL
Standard Deviation 28687.6
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)
Week 8 (n=4, 6, 2, 5, 2)
|
-9690.0 pg/mL
Standard Deviation 13732.0
|
-13440.0 pg/mL
Standard Deviation 27749.2
|
18971.7 pg/mL
Standard Deviation 30883.3
|
-6230.0 pg/mL
Standard Deviation 7028.6
|
6306.0 pg/mL
Standard Deviation 24845.5
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)
Week 4 (n=3, 4, 2, 4, 3)
|
14003.3 pg/mL
Standard Deviation 22925.3
|
-633.3 pg/mL
Standard Deviation 1325.5
|
-47485.0 pg/mL
Standard Deviation 110811.6
|
21025.0 pg/mL
Standard Deviation 45078.1
|
-18020.0 pg/mL
Standard Deviation 44942.7
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)
Week 8 (n=4, 5, 2, 5, 2)
|
-4220.0 pg/mL
Standard Deviation 5741.7
|
-34722.5 pg/mL
Standard Deviation 62344.4
|
3118.0 pg/mL
Standard Deviation 23681.2
|
-10150.0 pg/mL
Standard Deviation 2899.1
|
22148.0 pg/mL
Standard Deviation 36704.1
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)
Week 4 (n=4, 5, 2, 4, 3)
|
-301.3 pg/mL
Standard Deviation 1138.3
|
1.3 pg/mL
Standard Deviation 541.7
|
47.4 pg/mL
Standard Deviation 281.2
|
630.0 pg/mL
Standard Deviation 325.3
|
-1562.5 pg/mL
Standard Deviation 2787.4
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)
Week 8 (n=4, 6, 2, 5, 3)
|
246.7 pg/mL
Standard Deviation 331.6
|
-1237.8 pg/mL
Standard Deviation 1975.3
|
534.5 pg/mL
Standard Deviation 868.9
|
-360.0 pg/mL
Standard Deviation 1004.1
|
-327.6 pg/mL
Standard Deviation 2083.1
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)
Week 4 (n=4, 5, 2, 4, 3)
|
19.43 pg/mL
Standard Deviation 51.60
|
13.25 pg/mL
Standard Deviation 31.28
|
-12.06 pg/mL
Standard Deviation 70.14
|
21.50 pg/mL
Standard Deviation 40.31
|
-28.98 pg/mL
Standard Deviation 57.50
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)
Week 8 (n=4, 6, 2, 5, 3)
|
-8.93 pg/mL
Standard Deviation 15.77
|
-61.48 pg/mL
Standard Deviation 79.46
|
-3.83 pg/mL
Standard Deviation 81.17
|
6.50 pg/mL
Standard Deviation 36.06
|
-9.58 pg/mL
Standard Deviation 49.45
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)
Week 4 (n=4, 5, 2, 4, 3)
|
142.3 ng/mL
Standard Deviation 375.9
|
12.5 ng/mL
Standard Deviation 85.9
|
-19.8 ng/mL
Standard Deviation 73.5
|
124.5 ng/mL
Standard Deviation 173.2
|
-131.8 ng/mL
Standard Deviation 165.9
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)
Week 8 (n=4, 6, 2, 5, 3)
|
114.0 ng/mL
Standard Deviation 167.7
|
-48.5 ng/mL
Standard Deviation 69.8
|
34.3 ng/mL
Standard Deviation 75.2
|
-109.0 ng/mL
Standard Deviation 168.3
|
-76.8 ng/mL
Standard Deviation 88.1
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor
Week 4 (n=4, 5, 2, 4, 3)
|
-121.7 pg/mL
Standard Deviation 1815.2
|
-0.5 pg/mL
Standard Deviation 495.3
|
-213.2 pg/mL
Standard Deviation 1803.5
|
-138.5 pg/mL
Standard Deviation 186.0
|
0.5 pg/mL
Standard Deviation 3816.2
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor
Week 8 (n=4, 6, 2, 5, 3)
|
-212.7 pg/mL
Standard Deviation 532.5
|
-15.5 pg/mL
Standard Deviation 370.2
|
361.0 pg/mL
Standard Deviation 857.7
|
-885.0 pg/mL
Standard Deviation 1322.3
|
-122.0 pg/mL
Standard Deviation 1612.5
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin
Week 4 (n=4, 5, 2, 4, 3)
|
164.67 mcg/mL
Standard Deviation 73.04
|
-228.00 mcg/mL
Standard Deviation 409.55
|
-28.20 mcg/mL
Standard Deviation 94.15
|
42.50 mcg/mL
Standard Deviation 181.73
|
111.75 mcg/mL
Standard Deviation 293.07
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin
Week 8 (n=4, 6, 2, 5, 3)
|
81.33 mcg/mL
Standard Deviation 75.63
|
99.50 mcg/mL
Standard Deviation 354.15
|
125.17 mcg/mL
Standard Deviation 292.09
|
1.00 mcg/mL
Standard Deviation 147.08
|
96.00 mcg/mL
Standard Deviation 141.26
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC
Week 4 (n=3, 5, 2, 4, 3)
|
1651.67 Relative unit/mL
Standard Deviation 7544.36
|
1704.00 Relative unit/mL
Standard Deviation 4222.07
|
-871.40 Relative unit/mL
Standard Deviation 4857.15
|
383.00 Relative unit/mL
Standard Deviation 24.04
|
-35221.50 Relative unit/mL
Standard Deviation 67264.76
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC
Week 8 (n=4, 6, 2, 5, 3)
|
-1698.33 Relative unit/mL
Standard Deviation 2346.05
|
-18222.00 Relative unit/mL
Standard Deviation 32490.62
|
487.83 Relative unit/mL
Standard Deviation 5164.47
|
6926.00 Relative unit/mL
Standard Deviation 10004.15
|
-35105.40 Relative unit/mL
Standard Deviation 84919.27
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.
Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4
Week 4
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4
Week 8
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125
Week 4 (n=4, 5, 2, 4, 3)
|
130.0 Relative unit/mL
Standard Deviation 178.0
|
44.8 Relative unit/mL
Standard Deviation 337.3
|
-228.6 Relative unit/mL
Standard Deviation 1493.7
|
-41.0 Relative unit/mL
Standard Deviation 312.5
|
-648.5 Relative unit/mL
Standard Deviation 1710.9
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125
Week 8 (n=4, 6, 2, 5, 3)
|
-289.3 Relative unit/mL
Standard Deviation 86.8
|
-487.3 Relative unit/mL
Standard Deviation 364.0
|
4.0 Relative unit/mL
Standard Deviation 910.5
|
265.5 Relative unit/mL
Standard Deviation 685.2
|
-427.6 Relative unit/mL
Standard Deviation 1479.9
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1
Week 4 (n=4, 5, 2, 4, 3)
|
-5.3 Relative unit/mL
Standard Deviation 23.5
|
41.0 Relative unit/mL
Standard Deviation 35.6
|
194.8 Relative unit/mL
Standard Deviation 428.5
|
79.5 Relative unit/mL
Standard Deviation 89.8
|
-328.5 Relative unit/mL
Standard Deviation 634.9
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1
Week 8 (n=4, 6, 2, 5, 3)
|
-15.3 Relative unit/mL
Standard Deviation 23.2
|
-97.0 Relative unit/mL
Standard Deviation 183.0
|
33.5 Relative unit/mL
Standard Deviation 124.2
|
30.5 Relative unit/mL
Standard Deviation 57.3
|
-80.2 Relative unit/mL
Standard Deviation 200.1
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1
Week 4 (n=4, 5, 2, 4, 3)
|
573.00 mcg/mL
Standard Deviation 8434.01
|
-17.00 mcg/mL
Standard Deviation 2539.88
|
257.00 mcg/mL
Standard Deviation 382.18
|
-3115.50 mcg/mL
Standard Deviation 4418.71
|
-651.00 mcg/mL
Standard Deviation 659.50
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1
Week 8 (n=4, 6, 2, 5, 3)
|
-417.00 mcg/mL
Standard Deviation 4540.91
|
-1524.50 mcg/mL
Standard Deviation 2083.82
|
588.67 mcg/mL
Standard Deviation 1504.14
|
-3560.00 mcg/mL
Standard Deviation 5048.74
|
222.60 mcg/mL
Standard Deviation 1420.46
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4 and 8Population: A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8. n=number of analyzed with sufficient quantity for testing.
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Outcome measures
| Measure |
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=11 Participants
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Japan
n=17 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=14 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=9 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=8 Participants
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops Vehicle Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein
Week 4 (n=4, 5, 2, 4, 3)
|
6328.3 mcg/mL
Standard Deviation 17461.8
|
748.8 mcg/mL
Standard Deviation 4116.3
|
-956.0 mcg/mL
Standard Deviation 4190.6
|
1180.0 mcg/mL
Standard Deviation 311.1
|
-8281.3 mcg/mL
Standard Deviation 13425.6
|
—
|
—
|
—
|
—
|
|
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein
Week 8 (n=4, 6, 2, 5, 3)
|
5195.0 mcg/mL
Standard Deviation 9724.4
|
-2322.5 mcg/mL
Standard Deviation 4827.1
|
836.7 mcg/mL
Standard Deviation 4104.5
|
-5695.0 mcg/mL
Standard Deviation 8605.5
|
-3070.0 mcg/mL
Standard Deviation 4798.4
|
—
|
—
|
—
|
—
|
Adverse Events
CP-690,550 Eye Drops Vehicle Group in Japan
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
CP-690,550 Eye Drops 0.001% Group in Japan
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
CP-690,550 Eye Drops 0.003% Group in Japan
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
CP-690,550 Eye Drops 0.005% Group in Japan
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
CP-690,550 Eye Drops Vehicle Group in Korea
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CP-690,550 Eye Drops 0.001% Group in Korea
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CP-690,550 Eye Drops 0.003% Group in Korea
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CP-690,550 Eye Drops 0.005% Group in Korea
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 participants at risk
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Korea
n=21 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
n=19 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
n=21 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
n=21 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
CP-690,550 Eye Drops Vehicle Group in Japan
n=41 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Japan
n=42 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Japan
n=41 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Japan
n=40 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
Sodium Hyaluronate Eye Drops 0.1% Group in Japan
n=39 participants at risk
At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
|
CP-690,550 Eye Drops Vehicle Group in Korea
n=21 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.001% Group in Korea
n=19 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.003% Group in Korea
n=21 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
CP-690,550 Eye Drops 0.005% Group in Korea
n=21 participants at risk
At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
|
|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival erosion
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival hyperaemia
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Dry eye
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye discharge
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye irritation
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
3/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.8%
3/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.5%
2/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.5%
2/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Keratitis
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.5%
2/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Keratopathy
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Photopsia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.5%
2/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Adenoviral conjunctivitis
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
2/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.5%
4/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
2/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
5/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood triglycerides increased
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Optic nerve cup/disc ratio increased
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.5%
2/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
3/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/42
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER