Trial Outcomes & Findings for The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis. (NCT NCT04207736)
NCT ID: NCT04207736
Last Updated: 2024-11-20
Results Overview
Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
COMPLETED
PHASE3
95 participants
The efficacy assessment period was 110 to 210 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.
2024-11-20
Participant Flow
Ninety-five subjects were randomized in a crossover design trial; efficacy was assessed in an allergy chamber.
Participant milestones
| Measure |
Reproxalap (0.25%), Then Vehicle
Subjects first received reproxalap ophthalmic solution 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 (0.25%)
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 twice in a single day.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
|
Overall Study
COMPLETED
|
46
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
Baseline characteristics by cohort
| Measure |
Reproxalap (0.25%), Then Vehicle
n=48 Participants
Subjects first received reproxalap ophthalmic solution 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 (0.25%)
n=47 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 twice in a single day.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 13.41 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 11.13 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 12.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The efficacy assessment period was 110 to 210 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=95 Participants
Reproxalap ophthalmic solution was dosed twice in a single day.
|
Vehicle
n=95 Participants
Vehicle ophthalmic solution was dosed twice in a single day.
|
|---|---|---|
|
Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber
|
0.94 score on a scale
Standard Error 0.08
|
1.38 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: The efficacy assessment period was 12 to 212 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = none, 4 = extremely severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
Outcome measures
| Measure |
Reproxalap (0.25%)
n=95 Participants
Reproxalap ophthalmic solution was dosed twice in a single day.
|
Vehicle
n=95 Participants
Vehicle ophthalmic solution was dosed twice in a single day.
|
|---|---|---|
|
Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber
|
0.51 score on a scale
Standard Error 0.03
|
0.65 score on a scale
Standard Error 0.03
|
Adverse Events
Reproxalap (0.25%)
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reproxalap (0.25%)
n=91 participants at risk
Reproxalap ophthalmic solution was dosed twice in a single day.
|
Vehicle
n=93 participants at risk
Vehicle ophthalmic solution was dosed twice in a single day.
|
|---|---|---|
|
General disorders
General disorders and administrations site conditions
|
74.7%
68/91 • The period of time over which adverse events were collected was approximately one day for each intervention.
|
6.5%
6/93 • The period of time over which adverse events were collected was approximately one day for each intervention.
|
|
Eye disorders
Eye disoders
|
8.8%
8/91 • The period of time over which adverse events were collected was approximately one day for each intervention.
|
0.00%
0/93 • The period of time over which adverse events were collected was approximately one day for each intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place