Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease (NCT NCT05424549)

Last Updated: 2025-01-15

Results Overview

Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.

Results posted on

2025-01-15

Participant Flow

Sixty-three subjects were randomized in a crossover design.

Participant milestones

Participant milestones
Measure	Reproxalap (0.25%) First, Then Vehicle Subjects received reproxalap six times over two consecutive days, followed by a 7-day washout, then subjects received vehicle six times over two consecutive days.	Vehicle First, Then Reproxalap (0.25%) Subjects received vehicle six times over two consecutive days, followed by a 7-day washout, then subjects received reproxalap six times over two consecutive days.
Overall Study STARTED	32	31
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reproxalap (0.25%) First, Then Vehicle n=32 Participants Subjects received reproxalap six times over two consecutive days, followed by a 7-day washout, then subjects received vehicle six times over two consecutive days.	Vehicle First, Then Reproxalap (0.25%) n=31 Participants Subjects received vehicle six times over two consecutive days, followed by a 7-day washout, then subjects received reproxalap six times over two consecutive days.	Total n=63 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	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	47.0 years STANDARD_DEVIATION 13.12 • n=5 Participants	51.2 years STANDARD_DEVIATION 12.14 • n=7 Participants	49.1 years STANDARD_DEVIATION 12.72 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	7 Participants n=7 Participants	22 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	6 Participants n=5 Participants	6 Participants n=7 Participants	12 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	5 Participants n=7 Participants	5 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
Intraocular Pressure (right eye)	11.6 mmHg STANDARD_DEVIATION 2.08 • n=5 Participants	12.0 mmHg STANDARD_DEVIATION 2.76 • n=7 Participants	11.8 mmHg STANDARD_DEVIATION 2.42 • n=5 Participants
Intraocular Pressure (left eye)	11.7 mmHg STANDARD_DEVIATION 1.97 • n=5 Participants	11.6 mmHg STANDARD_DEVIATION 2.61 • n=7 Participants	11.6 mmHg STANDARD_DEVIATION 2.29 • n=5 Participants

PRIMARY outcome

Timeframe: The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.

Population: Intent-to-treat population

Outcome measures

Outcome measures
Measure	Reproxalap (0.25%) n=61 Participants Subjects received reproxalap six times over two consecutive days.	Vehicle n=61 Participants Subjects received vehicle six times over two consecutive days.
Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber	0.33 score on a scale Interval 0.23 to 0.43	0.44 score on a scale Interval 0.34 to 0.54

PRIMARY outcome

Timeframe: The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period.

Change from baseline comparison of reproxalap to vehicle for schirmer test on a millimeter line (0 = none, 35 = maximum). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.

Outcome measures

Outcome measures
Measure	Reproxalap (0.25%) n=61 Participants Subjects received reproxalap six times over two consecutive days.	Vehicle n=61 Participants Subjects received vehicle six times over two consecutive days.
Schirmer Test Mean Change From Baseline	-0.06 score on a scale Interval -1.82 to 1.7	-2.54 score on a scale Interval -4.22 to -0.86

Adverse Events

Reproxalap (0.25%)

Serious events: 0 serious events

Other events: 56 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Reproxalap (0.25%) n=61 participants at risk Subjects received reproxalap six times over two consecutive days.	Vehicle n=60 participants at risk Subjects received vehicle six times over two consecutive days.
General disorders General disorders and administration site conditions	91.8% 56/61 • Two days for each intervention	3.3% 2/60 • Two days for each intervention

Additional Information

Bill Cavanagh

Aldeyra Therapeutics, Inc.

Phone: 781-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place