Trial Outcomes & Findings for ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis (NCT NCT03494504)
NCT ID: NCT03494504
Last Updated: 2025-02-11
Results Overview
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
318 participants
Primary outcome timeframe
Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Results posted on
2025-02-11
Participant Flow
Participant milestones
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
Reproxalap administered once 10 minutes prior to pollen exposure
|
Reproxalap Ophthalmic Solution (0.5%)
Reproxalap administered once 10 minutes prior to pollen exposure
|
Vehicle Ophthalmic Solution
Vehicle administered once 10 minutes prior to pollen exposure
|
|---|---|---|---|
|
Overall Study
STARTED
|
109
|
100
|
109
|
|
Overall Study
COMPLETED
|
109
|
100
|
109
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=109 Participants
Reproxalap administered once 10 minutes prior to pollen exposure
|
Reproxalap Ophthalmic Solution (0.5%)
n=100 Participants
Reproxalap administered once 10 minutes prior to pollen exposure
|
Vehicle Ophthalmic Solution
n=109 Participants
Vehicle administered once 10 minutes prior to pollen exposure
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
282 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
109 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Blue
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Brown
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Hazel
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Green
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Gray
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Blue
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Brown
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Hazel
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Green
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Gray
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Randomization Stratum
<= 2.7 Average Baseline Itching Score
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Randomization Stratum
> 2.7 and <= 3.5 Average Baseline Itching Score
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Randomization Stratum
> 3.5 Average Baseline Itching Score
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.Population: Intent-to-treat population with observed data only
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
Outcome measures
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=109 Participants
Reproxalap administered once 10 minutes prior to pollen exposure
|
Reproxalap Ophthalmic Solution (0.5%)
n=100 Participants
Reproxalap administered once 10 minutes prior to pollen exposure
|
Vehicle Ophthalmic Solution
n=109 Participants
Vehicle administered once 10 minutes prior to pollen exposure
|
|---|---|---|---|
|
Subject-reported Ocular Itching Score
|
52.003 units on a scale*minutes
Standard Error 3.3053
|
60.040 units on a scale*minutes
Standard Error 3.4552
|
74.657 units on a scale*minutes
Standard Error 3.3076
|
SECONDARY outcome
Timeframe: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.Population: Intent-to-treat population with observed data only
The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed.
Outcome measures
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=109 Participants
Reproxalap administered once 10 minutes prior to pollen exposure
|
Reproxalap Ophthalmic Solution (0.5%)
n=100 Participants
Reproxalap administered once 10 minutes prior to pollen exposure
|
Vehicle Ophthalmic Solution
n=109 Participants
Vehicle administered once 10 minutes prior to pollen exposure
|
|---|---|---|---|
|
Number of Subjects With Two-point Reduction in Itching Score
|
88 Participants
|
77 Participants
|
77 Participants
|
Adverse Events
Reproxalap Ophthalmic Solution (0.25%)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Reproxalap Ophthalmic Solution (0.5%)
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=109 participants at risk
Reproxalap administered once 10 minutes prior to pollen exposure
|
Reproxalap Ophthalmic Solution (0.5%)
n=100 participants at risk
Reproxalap administered once 10 minutes prior to pollen exposure
|
Vehicle Ophthalmic Solution
n=109 participants at risk
Vehicle administered once 10 minutes prior to pollen exposure
|
|---|---|---|---|
|
General disorders
General disorders and administration site conditions
|
28.4%
31/109 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately two months.
|
41.0%
41/100 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately two months.
|
0.92%
1/109 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately two months.
|
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