Trial Outcomes & Findings for A Clinical Trial to Assess Subjects With Dry Eye Disease. (NCT NCT04971031)
NCT ID: NCT04971031
Last Updated: 2025-02-24
Results Overview
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects.
COMPLETED
PHASE2
158 participants
The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.
2025-02-24
Participant Flow
One hundred fifty-eight subjects were randomized in the trial.
Participant milestones
| Measure |
Reproxalap (0.25%)
Reproxalap ophthalmic solution administered 7 times over two consecutive days
|
Vehicle
Vehicle ophthalmic solution administered 7 times over two consecutive days
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
78
|
|
Overall Study
COMPLETED
|
79
|
75
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Assess Subjects With Dry Eye Disease.
Baseline characteristics by cohort
| Measure |
Reproxalap (0.25%)
n=80 Participants
Reproxalap ophthalmic solution administered 7 times over two consecutive days
|
Vehicle
n=78 Participants
Vehicle ophthalmic solution administered 7 times over two consecutive days
|
Total
n=158 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
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
142 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
67 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
78 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Iris Color (Right Eye)
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Blue
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Brown
|
44 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Hazel
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Green
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Gray
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Blue
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Brown
|
44 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Hazel
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Green
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Gray
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.Population: Intent-to-Treat Population with observed data only
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=80 Participants
Reproxalap ophthalmic solution administered 7 times over two consecutive days
|
Vehicle
n=78 Participants
Vehicle ophthalmic solution administered 7 times over two consecutive days
|
|---|---|---|
|
Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber
|
0.066 units on a scale
Standard Error 0.0346
|
0.183 units on a scale
Standard Error 0.0353
|
PRIMARY outcome
Timeframe: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.Population: Intent-to-Treat Population with observed data only
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort, 100 = maximal discomfort), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=80 Participants
Reproxalap ophthalmic solution administered 7 times over two consecutive days
|
Vehicle
n=78 Participants
Vehicle ophthalmic solution administered 7 times over two consecutive days
|
|---|---|---|
|
Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
|
-5.7 units on a scale
Standard Error 2.44
|
-3.8 units on a scale
Standard Error 2.51
|
PRIMARY outcome
Timeframe: The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.Population: Intent-to-Treat Population with observed data only
Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline and treatment group as fixed effects.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=80 Participants
Reproxalap ophthalmic solution administered 7 times over two consecutive days
|
Vehicle
n=78 Participants
Vehicle ophthalmic solution administered 7 times over two consecutive days
|
|---|---|---|
|
Schirmer Test Change From Baseline After the First Dose on Day 1
|
4.2 length in millimeters
Standard Error 0.83
|
2.1 length in millimeters
Standard Error 0.84
|
Adverse Events
Reproxalap (0.25%)
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reproxalap (0.25%)
n=79 participants at risk
Reproxalap ophthalmic solution administered 7 times over two consecutive days
|
Vehicle
n=77 participants at risk
Vehicle ophthalmic solution administered 7 times over two consecutive days
|
|---|---|---|
|
General disorders
General disorders and administration site conditions
|
65.8%
52/79 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately one week.
There were 158 subjects randomized in the trial (Intent-to-treat population). There were 156 subjects exposed to study drug (Safety population). Collection of adverse events is based on the Safety population.
|
3.9%
3/77 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately one week.
There were 158 subjects randomized in the trial (Intent-to-treat population). There were 156 subjects exposed to study drug (Safety population). Collection of adverse events is based on the Safety population.
|
Additional Information
Sr. Director, Clinical Operations
Aldeyra Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place