Trial Outcomes & Findings for The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis (NCT NCT05234554)
NCT ID: NCT05234554
Last Updated: 2026-05-14
Results Overview
The method of assessment was a 9-point ocular itch scale measured in half-unit increments (0 none - 4 severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 210 ten minutes in duration with the itching assessment being collected every 10 minutes from 110 to 210 minutes. The timepoints were assessed using mixed model repeated measures.
COMPLETED
PHASE3
131 participants
110 to 210 minutes during allergen chamber exposure
2026-05-14
Participant Flow
Participant milestones
| Measure |
Reproxalap, Then Vehicle
Subjects first received reproxalap ophthalmic solution (0.25%) twice in a single day. After a washout period of approximately two weeks, subjects then received vehicle ophthalmic solution twice in a single day.
|
Vehicle, Then Reproxalap
Subjects first received vehicle ophthalmic solution twice in a single day. After a washout period of approximately two weeks, subjects then received reproxalap ophthalmic solution (0.25%) twice in a single day.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
65
|
|
Overall Study
COMPLETED
|
66
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
Reproxalap, Then Vehicle
n=66 Participants
Subjects first received reproxalap ophthalmic solution (0.25%) twice in a single day. After a washout period of approximately two weeks, subjects then received vehicle ophthalmic solution twice in a single day.
|
Vehicle, Then Reproxalap
n=65 Participants
Subjects first received vehicle ophthalmic solution twice in a single day. After a washout period of approximately two weeks, subjects then received reproxalap ophthalmic solution (0.25%) twice in a single day.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 11.0 • n=1512 Participants
|
41.9 years
STANDARD_DEVIATION 12.5 • n=504 Participants
|
41.4 years
STANDARD_DEVIATION 11.7 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=1512 Participants
|
34 Participants
n=504 Participants
|
72 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=1512 Participants
|
31 Participants
n=504 Participants
|
59 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
17 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=1512 Participants
|
55 Participants
n=504 Participants
|
114 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
21 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=1512 Participants
|
17 Participants
n=504 Participants
|
28 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=1512 Participants
|
34 Participants
n=504 Participants
|
71 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
Canada
|
66 participants
n=1512 Participants
|
65 participants
n=504 Participants
|
131 participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: 110 to 210 minutes during allergen chamber exposurePopulation: Intent-to-treat population
The method of assessment was a 9-point ocular itch scale measured in half-unit increments (0 none - 4 severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 210 ten minutes in duration with the itching assessment being collected every 10 minutes from 110 to 210 minutes. The timepoints were assessed using mixed model repeated measures.
Outcome measures
| Measure |
Reproxalap
n=131 Participants
Reproxalap ophthalmic solution (0.25%) was dosed twice in a single day.
|
Vehicle
n=131 Participants
Vehicle ophthalmic solution was dosed twice in a single day.
|
|---|---|---|
|
Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber
|
1.48 units on a scale
Standard Error 0.07
|
1.84 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 12 to 212 minutes during allergen chamber exposurePopulation: Intent-to-treat population
The method of assessment was a 9-point ocular redness scale measured in half-unit increments (0 none - 4 extremely severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 212 minutes in duration with the redness assessment being collected every 10 minutes from 12 to 212 minutes. The timepoints were assessed using mixed model repeated measures.
Outcome measures
| Measure |
Reproxalap
n=131 Participants
Reproxalap ophthalmic solution (0.25%) was dosed twice in a single day.
|
Vehicle
n=131 Participants
Vehicle ophthalmic solution was dosed twice in a single day.
|
|---|---|---|
|
Conjunctival Redness Evaluated by the Investigator
|
0.69 units on a scale
Standard Error 0.02
|
0.71 units on a scale
Standard Error 0.02
|
Adverse Events
Reproxalap
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reproxalap
n=130 participants at risk
Reproxalap ophthalmic solution (0.25%) was dosed twice in a single day.
|
Vehicle
n=131 participants at risk
Vehicle ophthalmic solution was dosed twice in a single day.
|
|---|---|---|
|
General disorders
General disorders and administration site conditions
|
71.5%
93/130 • Number of events 93 • The safety assessment period was approximately 4 hours on the study day for each intervention.
|
3.8%
5/131 • Number of events 5 • The safety assessment period was approximately 4 hours on the study day for each intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place