Trial Outcomes & Findings for A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis (NCT NCT02578914)
NCT ID: NCT02578914
Last Updated: 2023-12-05
Results Overview
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
The efficacy assessment period was assessed at Day 14; baseline was Day -7.
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
NS2 Ophthalmic Drops (0.5%)
NS2 administered QID (four times daily) for approximately 2 weeks
|
Vehicle Ophthalmic Drops
Vehicle administered QID for approximately 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
48
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
NS2 Ophthalmic Drops (0.5%)
n=50 Participants
NS2 administered QID for approximately 2 weeks
|
Vehicle Ophthalmic Drops
n=50 Participants
Vehicle administered QID for approximately 2 weeks
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian / other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The efficacy assessment period was assessed at Day 14; baseline was Day -7.Population: Intent-to-treat population
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
Outcome measures
| Measure |
NS2 Ophthalmic Drops (0.5%)
n=50 Participants
NS2 administered QID for approximately 2 weeks
|
Vehicle Ophthalmic Drops
n=50 Participants
Vehicle administered QID for approximately 2 weeks
|
|---|---|---|
|
Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
|
-1.550 units on a scale
Standard Error 0.168
|
-1.013 units on a scale
Standard Error 0.163
|
Adverse Events
NS2 Ophthalmic Drops (0.5%)
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Vehicle Ophthalmic Drops
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NS2 Ophthalmic Drops (0.5%)
n=50 participants at risk
NS2 administered QID for approximately 2 weeks
|
Vehicle Ophthalmic Drops
n=50 participants at risk
Vehicle administered QID for approximately 2 weeks
|
|---|---|---|
|
General disorders
General disorders and administration site conditions
|
98.0%
49/50 • The period of time over which adverse events were collected for each subject was approximately 9 weeks.
|
8.0%
4/50 • The period of time over which adverse events were collected for each subject was approximately 9 weeks.
|
|
Eye disorders
Lacrimination increased
|
6.0%
3/50 • The period of time over which adverse events were collected for each subject was approximately 9 weeks.
|
0.00%
0/50 • The period of time over which adverse events were collected for each subject was approximately 9 weeks.
|
|
Eye disorders
Punctate keratitis
|
6.0%
3/50 • The period of time over which adverse events were collected for each subject was approximately 9 weeks.
|
4.0%
2/50 • The period of time over which adverse events were collected for each subject was approximately 9 weeks.
|
|
Nervous system disorders
Headache
|
12.0%
6/50 • The period of time over which adverse events were collected for each subject was approximately 9 weeks.
|
10.0%
5/50 • The period of time over which adverse events were collected for each subject was approximately 9 weeks.
|
Additional Information
Sr. Director, Clinical Operations
Aldeyra Therapeutics, Inc.
Phone: 781-257-3063
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place