Trial Outcomes & Findings for CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (NCT NCT03292809)
NCT ID: NCT03292809
Last Updated: 2022-12-22
Results Overview
CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
328 participants
Primary outcome timeframe
baseline and 1 month [day 29]
Results posted on
2022-12-22
Participant Flow
After a 2-week run-in period, eligible DED patients were randomized 1:1 to either CyclASol 0.1% or vehicle twice daily.
Participant milestones
| Measure |
CyclASol Ophthalmic Solution
Cylclosporine A solution in vehicle
CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle
|
Vehicle Ophthalmic Solution
Vehicle only
Vehicle topical ocular, eye drops: Vehicle
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
166
|
|
Overall Study
COMPLETED
|
155
|
163
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Baseline characteristics by cohort
| Measure |
CyclASol Ophthalmic Solution
n=162 Participants
Cylclosporine A solution in vehicle
CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle
|
Vehicle Ophthalmic Solution
n=166 Participants
Vehicle only
Vehicle topical ocular, eye drops: Vehicle
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 13.6 • n=93 Participants
|
61.3 years
STANDARD_DEVIATION 12.66 • n=4 Participants
|
61.4 years
STANDARD_DEVIATION 13.11 • n=27 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
235 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=93 Participants
|
155 Participants
n=4 Participants
|
302 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=93 Participants
|
127 Participants
n=4 Participants
|
257 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
162 participants
n=93 Participants
|
166 participants
n=4 Participants
|
328 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 month [day 29]CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Outcome measures
| Measure |
CyclASol Ophthalmic Solution
n=162 Participants
Cylclosporine A solution in vehicle
CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle
|
Vehicle Ophthalmic Solution
n=166 Participants
Vehicle only
Vehicle topical ocular, eye drops: Vehicle
|
|---|---|---|
|
Change From Baseline in Total Corneal Fluorescein Staining at Day 29
|
-2.9 score on a scale
Standard Deviation 2.59
|
-2.2 score on a scale
Standard Deviation 2.73
|
PRIMARY outcome
Timeframe: baseline and 1 month [day 29]The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index.
Outcome measures
| Measure |
CyclASol Ophthalmic Solution
n=162 Participants
Cylclosporine A solution in vehicle
CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle
|
Vehicle Ophthalmic Solution
n=166 Participants
Vehicle only
Vehicle topical ocular, eye drops: Vehicle
|
|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index at Day 29
|
-7.08 score on a scale
Standard Deviation 18.650
|
-5.37 score on a scale
Standard Deviation 15.291
|
Adverse Events
CyclASol Ophthalmic Solution
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CyclASol Ophthalmic Solution
n=162 participants at risk
Cylclosporine A solution in vehicle
CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle
|
Vehicle Ophthalmic Solution
n=166 participants at risk
Vehicle only
Vehicle topical ocular, eye drops: Vehicle
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/162 • 85 Days ± 2 (Randomization until Study Exit)
|
0.60%
1/166 • Number of events 1 • 85 Days ± 2 (Randomization until Study Exit)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/162 • 85 Days ± 2 (Randomization until Study Exit)
|
0.60%
1/166 • Number of events 1 • 85 Days ± 2 (Randomization until Study Exit)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/162 • 85 Days ± 2 (Randomization until Study Exit)
|
0.60%
1/166 • Number of events 1 • 85 Days ± 2 (Randomization until Study Exit)
|
Other adverse events
| Measure |
CyclASol Ophthalmic Solution
n=162 participants at risk
Cylclosporine A solution in vehicle
CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle
|
Vehicle Ophthalmic Solution
n=166 participants at risk
Vehicle only
Vehicle topical ocular, eye drops: Vehicle
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
3.1%
5/162 • 85 Days ± 2 (Randomization until Study Exit)
|
1.8%
3/166 • 85 Days ± 2 (Randomization until Study Exit)
|
|
Eye disorders
Instillation site pain
|
2.5%
4/162 • 85 Days ± 2 (Randomization until Study Exit)
|
1.2%
2/166 • 85 Days ± 2 (Randomization until Study Exit)
|
|
Eye disorders
Vision blurred
|
1.2%
2/162 • 85 Days ± 2 (Randomization until Study Exit)
|
2.4%
4/166 • 85 Days ± 2 (Randomization until Study Exit)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
8/162 • 85 Days ± 2 (Randomization until Study Exit)
|
4.2%
7/166 • 85 Days ± 2 (Randomization until Study Exit)
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
7/162 • 85 Days ± 2 (Randomization until Study Exit)
|
4.2%
7/166 • 85 Days ± 2 (Randomization until Study Exit)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60