Trial Outcomes & Findings for A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease (NCT NCT03404115)
NCT ID: NCT03404115
Last Updated: 2025-02-06
Results Overview
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort \& 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
300 participants
Primary outcome timeframe
Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
|
Reproxalap Ophthalmic Solution (0.1%)
Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
|
Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
|
Overall Study
COMPLETED
|
97
|
88
|
99
|
|
Overall Study
NOT COMPLETED
|
3
|
12
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=100 Participants
Reproxalap Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
|
Reproxalap Ophthalmic Solution (0.1%)
n=100 Participants
Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
|
Vehicle Ophthalmic Solution
n=100 Participants
Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks.
|
Total
n=300 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
|
58 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
293 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
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
100 participants
n=5 Participants
|
300 participants
n=4 Participants
|
|
Iris Color (Right Eye)
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Blue
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Brown
|
55 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Green
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Hazel
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Iris Color (Right Eye)
Gray
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 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
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Blue
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Brown
|
55 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Green
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Hazel
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Iris Color (Left Eye)
Gray
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 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
|
PRIMARY outcome
Timeframe: Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.Population: Intent to treat population with observed data only.
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort \& 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=100 Participants
Reproxalap Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
|
Reproxalap (0.1%)
n=100 Participants
Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
|
Vehicle
n=100 Participants
Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks.
|
|---|---|---|---|
|
Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.
|
-0.7 units on a scale
Standard Error 0.09
|
-0.5 units on a scale
Standard Error 0.08
|
-0.4 units on a scale
Standard Error 0.08
|
Adverse Events
Reproxalap Ophthalmic Solution (0.25%)
Serious events: 1 serious events
Other events: 93 other events
Deaths: 0 deaths
Reproxalap Ophthalmic Solution (0.1%)
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=100 participants at risk
Reproxalap Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
|
Reproxalap Ophthalmic Solution (0.1%)
n=100 participants at risk
Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
|
Vehicle Ophthalmic Solution
n=100 participants at risk
Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.0%
1/100 • The period of time when adverse events were collected was approximately 3 months.
|
0.00%
0/100 • The period of time when adverse events were collected was approximately 3 months.
|
0.00%
0/100 • The period of time when adverse events were collected was approximately 3 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/100 • The period of time when adverse events were collected was approximately 3 months.
|
1.0%
1/100 • The period of time when adverse events were collected was approximately 3 months.
|
0.00%
0/100 • The period of time when adverse events were collected was approximately 3 months.
|
Other adverse events
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=100 participants at risk
Reproxalap Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
|
Reproxalap Ophthalmic Solution (0.1%)
n=100 participants at risk
Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
|
Vehicle Ophthalmic Solution
n=100 participants at risk
Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks.
|
|---|---|---|---|
|
General disorders
General disorders and administration site conditions
|
93.0%
93/100 • The period of time when adverse events were collected was approximately 3 months.
|
37.0%
37/100 • The period of time when adverse events were collected was approximately 3 months.
|
2.0%
2/100 • The period of time when adverse events were collected was approximately 3 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