Trial Outcomes & Findings for A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease (NCT NCT03916042)
NCT ID: NCT03916042
Last Updated: 2025-03-03
Results Overview
Change from baseline comparison of reproxalap to vehicle for subject-reported Ocular Dryness Score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The Least Squares Mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
206 participants
Primary outcome timeframe
Efficacy assessment period (Day 1 through 85) - assessed at Weeks 1, 2, 4, 6, 8, 10, and 12. Baseline was Day 1.
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
Reproxalap (0.25% Novel Formulation)
Reproxalap ophthalmic solution administered QID (four times daily) for four weeks, followed by BID (two times daily) administration for eight weeks
|
Vehicle
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
104
|
|
Overall Study
COMPLETED
|
96
|
97
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Reproxalap (0.25% Novel Formulation)
n=102 Participants
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle
n=104 Participants
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Total
n=206 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
|
52 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
190 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
89 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
104 participants
n=7 Participants
|
206 participants
n=5 Participants
|
|
Iris Color (Right Eye)
Black
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Blue
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Brown
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Hazel
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Gray
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Green
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 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
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Blue
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Brown
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Hazel
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Gray
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Green
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 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: Efficacy assessment period (Day 1 through 85) - assessed at Weeks 1, 2, 4, 6, 8, 10, and 12. Baseline was Day 1.Population: Intent-to-treat Ocular Dryness 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 higher score means a worse outcome. The intervention was administered bilaterally. The Least Squares Mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Outcome measures
| Measure |
Reproxalap (0.25% Novel Formulation)
n=82 Participants
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle
n=83 Participants
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
|---|---|---|
|
Change From Baseline in Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
|
-16.0 score on a scale
Standard Error 2.20
|
-9.1 score on a scale
Standard Error 2.18
|
Adverse Events
Reproxalap (0.25% Novel Formulation)
Serious events: 1 serious events
Other events: 91 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reproxalap (0.25% Novel Formulation)
n=102 participants at risk
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle
n=104 participants at risk
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/102 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.96%
1/104 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Infections and infestations
Cellulitis
|
0.98%
1/102 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/104 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
Other adverse events
| Measure |
Reproxalap (0.25% Novel Formulation)
n=102 participants at risk
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle
n=104 participants at risk
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
8.8%
9/102 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
3.8%
4/104 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
General disorders
General disorders and administration site conditions
|
80.4%
82/102 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
3.8%
4/104 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three 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