Trial Outcomes & Findings for A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (NCT NCT03709121)
NCT ID: NCT03709121
Last Updated: 2025-02-24
Results Overview
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
COMPLETED
PHASE1/PHASE2
70 participants
Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
2025-02-24
Participant Flow
Seventy subjects were randomized in a three-way crossover design trial.
Participant milestones
| Measure |
Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle
Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%)
Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%)
Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
25
|
23
|
|
Overall Study
COMPLETED
|
22
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber
Baseline characteristics by cohort
| Measure |
Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle
n=22 Participants
Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%)
n=25 Participants
Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Vehicle) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%)
n=23 Participants
Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Mean
|
45.50 years
n=99 Participants
|
48.84 years
n=107 Participants
|
46.17 years
n=206 Participants
|
46.9 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian / Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other - Mixed
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
22 participants
n=99 Participants
|
25 participants
n=107 Participants
|
23 participants
n=206 Participants
|
70 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.Population: Intent-to-treat population
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=67 Participants
Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Reproxalap (0.5%)
n=69 Participants
Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Vehicle
n=67 Participants
Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
|---|---|---|---|
|
Subject-Reported Ocular Itching Score
|
16.410 units on a scale
Standard Error 1.6195
|
16.964 units on a scale
Standard Error 1.6150
|
22.310 units on a scale
Standard Error 1.6188
|
SECONDARY outcome
Timeframe: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.Population: Intent-to-treat population
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular tearing score from 0 to 212 minutes in the allergen chamber using a 4-point scale (0 = none, 3 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=67 Participants
Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Reproxalap (0.5%)
n=69 Participants
Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Vehicle
n=67 Participants
Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
|---|---|---|---|
|
Subject-Reported Ocular Tearing Score
|
0.8777 units on a scale
Standard Error 0.0615
|
0.8915 units on a scale
Standard Error 0.0613
|
1.0507 units on a scale
Standard Error 0.0614
|
SECONDARY outcome
Timeframe: Efficacy was assessed from 0 to 210 minutes in the allergen chamber.Population: Intent-to-treat population
Change from baseline comparison of reproxalap to vehicle for investigator-assessed conjunctival redness from 0 to 210 minutes in the allergen chamber using a 9-point scale with half unit increments (0 = normal, 4 = prominent) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=67 Participants
Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Reproxalap (0.5%)
n=69 Participants
Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Vehicle
n=67 Participants
Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
|---|---|---|---|
|
Investigator-Assessed Conjunctival Redness Score
|
0.5004 units on a scale
Standard Error 0.0458
|
0.5462 units on a scale
Standard Error 0.0457
|
0.6497 units on a scale
Standard Error 0.0458
|
Adverse Events
Reproxalap (0.25%)
Reproxalap (0.5%)
Vehicle Ophthalmic Solution
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reproxalap (0.25%)
n=67 participants at risk
Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Reproxalap (0.5%)
n=69 participants at risk
Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
Vehicle Ophthalmic Solution
n=67 participants at risk
Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry.
|
|---|---|---|---|
|
General disorders
General disorders and administration site conditions
|
73.1%
49/67 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately fourteen weeks.
|
81.2%
56/69 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately fourteen weeks.
|
7.5%
5/67 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately fourteen weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place