Trial Outcomes & Findings for A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED) (NCT NCT03652051)
NCT ID: NCT03652051
Last Updated: 2024-02-28
Results Overview
Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
321 participants
Primary outcome timeframe
Value at month 3 minus value at baseline
Results posted on
2024-02-28
Participant Flow
Participant milestones
| Measure |
AZR-MD-001 Low Dose
AZR-MD-001 Low Dose was dosed twice weekly.
AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment
|
AZR-MD-001 Mid Dose
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
AZR-MD-001 High Dose
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
AZR-MD-001 Vehicle
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
|---|---|---|---|---|
|
Stage 1
STARTED
|
9
|
27
|
24
|
16
|
|
Stage 1
COMPLETED
|
9
|
22
|
16
|
15
|
|
Stage 1
NOT COMPLETED
|
0
|
5
|
8
|
1
|
|
Stage 2
STARTED
|
0
|
82
|
83
|
80
|
|
Stage 2
COMPLETED
|
0
|
66
|
67
|
74
|
|
Stage 2
NOT COMPLETED
|
0
|
16
|
16
|
6
|
Reasons for withdrawal
| Measure |
AZR-MD-001 Low Dose
AZR-MD-001 Low Dose was dosed twice weekly.
AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment
|
AZR-MD-001 Mid Dose
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
AZR-MD-001 High Dose
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
AZR-MD-001 Vehicle
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
|---|---|---|---|---|
|
Stage 1
Adverse Event
|
0
|
5
|
7
|
1
|
|
Stage 1
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Stage 2
Adverse Event
|
0
|
2
|
1
|
0
|
|
Stage 2
Protocol Violation
|
0
|
1
|
6
|
0
|
|
Stage 2
Lost to Follow-up
|
0
|
2
|
0
|
3
|
|
Stage 2
Withdrawal by Subject
|
0
|
11
|
9
|
3
|
Baseline Characteristics
A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
Baseline characteristics by cohort
| Measure |
Stage 1: AZR-MD-001 Low Dose
n=9 Participants
AZR-MD-001 Low Dose was dosed twice weekly.
AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Mid Dose
n=27 Participants
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 High Dose
n=24 Participants
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Vehicle
n=16 Participants
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
Stage 2: AZR-MD-001 Mid Dose
n=82 Participants
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 High Dose
n=83 Participants
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 Vehicle
n=80 Participants
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 18.79 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 17.71 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 22.02 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 20.34 • n=4 Participants
|
52.1 years
STANDARD_DEVIATION 16.9 • n=21 Participants
|
55.6 years
STANDARD_DEVIATION 17.2 • n=10 Participants
|
51.9 years
STANDARD_DEVIATION 18.5 • n=115 Participants
|
53.2 years
STANDARD_DEVIATION 17.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
56 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
196 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
125 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
80 Participants
n=10 Participants
|
78 Participants
n=115 Participants
|
305 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
77 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
217 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
19 Participants
n=24 Participants
|
|
Meibomian Glands Yielding Liquid Secretion (Primary Sign Endpoint)
|
2.5 Gland Count (0 to 15)
STANDARD_DEVIATION 0.58 • n=5 Participants
|
2.8 Gland Count (0 to 15)
STANDARD_DEVIATION 1.26 • n=7 Participants
|
2.9 Gland Count (0 to 15)
STANDARD_DEVIATION 1.49 • n=5 Participants
|
2.8 Gland Count (0 to 15)
STANDARD_DEVIATION 1.64 • n=4 Participants
|
1.7 Gland Count (0 to 15)
STANDARD_DEVIATION 1.4 • n=21 Participants
|
1.9 Gland Count (0 to 15)
STANDARD_DEVIATION 1.4 • n=10 Participants
|
1.8 Gland Count (0 to 15)
STANDARD_DEVIATION 1.3 • n=115 Participants
|
1.8 Gland Count (0 to 15)
STANDARD_DEVIATION 1.3 • n=24 Participants
|
|
OSDI Total Score (Primary Symptom Endpoint)
|
25 Total Score (0 to 100)
STANDARD_DEVIATION 7.42 • n=5 Participants
|
23.1 Total Score (0 to 100)
STANDARD_DEVIATION 6.10 • n=7 Participants
|
21.34 Total Score (0 to 100)
STANDARD_DEVIATION 4.86 • n=5 Participants
|
22.64 Total Score (0 to 100)
STANDARD_DEVIATION 7.57 • n=4 Participants
|
25.2 Total Score (0 to 100)
STANDARD_DEVIATION 7.5 • n=21 Participants
|
24.2 Total Score (0 to 100)
STANDARD_DEVIATION 6 • n=10 Participants
|
25 Total Score (0 to 100)
STANDARD_DEVIATION 6.7 • n=115 Participants
|
24.8 Total Score (0 to 100)
STANDARD_DEVIATION 6.7 • n=24 Participants
|
PRIMARY outcome
Timeframe: Value at month 3 minus value at baselineChange from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Outcome measures
| Measure |
Stage 1: AZR-MD-001 Low Dose
n=9 Participants
AZR-MD-001 Low Dose was dosed twice weekly.
AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Mid Dose
n=27 Participants
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 High Dose
n=24 Participants
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Vehicle
n=16 Participants
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
Stage 2: AZR-MD-001 Mid Dose
n=82 Participants
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 High Dose
n=83 Participants
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 Vehicle
n=80 Participants
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
|---|---|---|---|---|---|---|---|
|
Meibomian Glands Yielding Liquid Secretion (MGYLS)
|
-0.7 Number of Open Glands
Standard Deviation 1.56
|
3.41 Number of Open Glands
Standard Deviation 0.8
|
3.07 Number of Open Glands
Standard Deviation 0.81
|
1.88 Number of Open Glands
Standard Deviation 1.38
|
4.2 Number of Open Glands
Standard Deviation 0.36
|
3.2 Number of Open Glands
Standard Deviation 0.4
|
2.4 Number of Open Glands
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: Value at month 3 minus value at baselineChange from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)
Outcome measures
| Measure |
Stage 1: AZR-MD-001 Low Dose
n=9 Participants
AZR-MD-001 Low Dose was dosed twice weekly.
AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Mid Dose
n=27 Participants
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 High Dose
n=24 Participants
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Vehicle
n=16 Participants
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
Stage 2: AZR-MD-001 Mid Dose
n=82 Participants
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 High Dose
n=83 Participants
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 Vehicle
n=80 Participants
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
|---|---|---|---|---|---|---|---|
|
Ocular Surface Disease Index (OSDI) Total Score
|
12.93 Scores on a Scale
Standard Deviation 4.62
|
-8.73 Scores on a Scale
Standard Deviation 2.37
|
-4.74 Scores on a Scale
Standard Deviation 2.41
|
-2.34 Scores on a Scale
Standard Deviation 4.09
|
-7.29 Scores on a Scale
Standard Deviation 1.3
|
-6.1 Scores on a Scale
Standard Deviation 1.3
|
-3.8 Scores on a Scale
Standard Deviation 1.2
|
Adverse Events
Stage 1: AZR-MD-001 Low Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 1: AZR-MD-001 Mid Dose
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Stage 1: AZR-MD-001 High Dose
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Stage 1: AZR-MD-001 Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 2: AZR-MD-001 Mid Dose
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Stage 2: AZR-MD-001 High Dose
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Stage 2: AZR-MD-001 Vehicle
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: AZR-MD-001 Low Dose
n=9 participants at risk
AZR-MD-001 Low Dose was dosed twice weekly.
AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Mid Dose
n=27 participants at risk
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 High Dose
n=24 participants at risk
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Vehicle
n=16 participants at risk
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
Stage 2: AZR-MD-001 Mid Dose
n=82 participants at risk
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 High Dose
n=83 participants at risk
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 Vehicle
n=80 participants at risk
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
pneumonia
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/27 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/82 • Number of events 1 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/83 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/27 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/82 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/83 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/80 • Number of events 80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/27 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/82 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/83 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/80 • Number of events 80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/27 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/82 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/83 • Number of events 83 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
n intervertebral disc protrusion
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/27 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.2%
1/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/82 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/83 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
ocular toxicity
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/27 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.2%
1/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/82 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/83 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
Other adverse events
| Measure |
Stage 1: AZR-MD-001 Low Dose
n=9 participants at risk
AZR-MD-001 Low Dose was dosed twice weekly.
AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Mid Dose
n=27 participants at risk
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 High Dose
n=24 participants at risk
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 1: AZR-MD-001 Vehicle
n=16 participants at risk
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
Stage 2: AZR-MD-001 Mid Dose
n=82 participants at risk
AZR-MD-001 Mid Dose was dosed twice weekly.
AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 High Dose
n=83 participants at risk
AZR-MD-001 High Dose was dosed twice weekly.
AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment
|
Stage 2: AZR-MD-001 Vehicle
n=80 participants at risk
AZR-MD-001 Vehicle was dosed twice weekly.
AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Application site pain
|
11.1%
1/9 • Number of events 9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
44.4%
12/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
37.5%
9/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
6.2%
1/16 • Number of events 11 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
17.1%
14/82 • Number of events 16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
15.7%
13/83 • Number of events 15 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
14.8%
4/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
12.5%
3/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
11.0%
9/82 • Number of events 9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/83 • Number of events 1 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
3.7%
1/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
9.8%
8/82 • Number of events 8 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
8.4%
7/83 • Number of events 15 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/80 • Number of events 2 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Vital dye staining cornea present
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
3.7%
1/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
8.3%
2/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
6.1%
5/82 • Number of events 7 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
8.4%
7/83 • Number of events 11 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/80 • Number of events 2 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Eye pain
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
11.1%
3/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
16.7%
4/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
6.1%
5/82 • Number of events 5 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
7.2%
6/83 • Number of events 10 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/80 • Number of events 1 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Eye irritation
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
25.9%
7/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
8.3%
2/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.9%
4/82 • Number of events 5 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
6.0%
5/83 • Number of events 7 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
2.5%
2/80 • Number of events 3 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Application site reaction
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
3.7%
1/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.2%
1/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.9%
4/82 • Number of events 5 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.8%
4/83 • Number of events 5 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Foreign body sensation
|
11.1%
1/9 • Number of events 9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
7.4%
2/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
8.3%
2/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
12.5%
2/16 • Number of events 11 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.9%
4/82 • Number of events 4 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
2.4%
2/83 • Number of events 2 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/80 • Number of events 1 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Administration site reaction
|
11.1%
1/9 • Number of events 9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
7.4%
2/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
29.2%
7/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
12.5%
2/16 • Number of events 11 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.9%
4/82 • Number of events 4 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/83 • Number of events 2 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Photophobia
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
18.5%
5/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
12.5%
3/24 • Number of events 24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
4.9%
4/82 • Number of events 4 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/83 • Number of events 1 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/80 • Number of events 1 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/27 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
3.7%
3/82 • Number of events 3 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
9.6%
8/83 • Number of events 9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
1.2%
1/80 • Number of events 1 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
|
Eye disorders
Application site irritation
|
0.00%
0/9 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
7.4%
2/27 • Number of events 32 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/24 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/16 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
2.4%
2/82 • Number of events 2 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
6.0%
5/83 • Number of events 5 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
0.00%
0/80 • 3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place