Trial Outcomes & Findings for An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber (NCT NCT05102409)

Last Updated: 2025-02-28

Results Overview

Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.

Results posted on

2025-02-28

Participant Flow

Fifty-six subjects were enrolled in a two-period crossover design trial in which each subject received lifitegrast and reproxalp during separate treatment periods separated by approximately 7 days. Subjects were dosed once for each treatment period just before entry into a 45-minute dry eye chamber.

Participant milestones

Participant milestones
Measure	Lifitegrast, Reproxalap Subjects received a single dose of 5% lifitegrast ophthalmic solution just before dry eye chamber entry, followed by a seven-day washout. Subjects then received a single dose of 0.25% reproxalap just before dry eye chamber entry.
Overall Study STARTED	56
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifitegrast, Reproxalap n=56 Participants Subjects received a single dose of 5% lifitegrast ophthalmic solution just before dry eye chamber entry, followed by a seven-day washout. Subjects then received a single dose of 0.25% reproxalap just before dry eye chamber entry.
Age, Continuous	47.9 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.

Population: Safety population

Outcome measures

Outcome measures
Measure	Reproxalap n=54 Participants Reproxalap dosed topically prior to dry eye chamber entry	Lifitegrast n=56 Participants Lifitegrast dosed topically prior to dry eye chamber entry
Change From Baseline in Ocular Discomfort	1.35 score on a scale Standard Error 0.21	2.07 score on a scale Standard Error 0.25

PRIMARY outcome

Timeframe: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.

Population: Safety population

Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.

Outcome measures

Outcome measures
Measure	Reproxalap n=54 Participants Reproxalap dosed topically prior to dry eye chamber entry	Lifitegrast n=56 Participants Lifitegrast dosed topically prior to dry eye chamber entry
Change From Baseline in Ocular Itching	0.93 score on a scale Standard Error 0.21	1.54 score on a scale Standard Error 0.25

Adverse Events

Reproxalap

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Lifitegrast

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Reproxalap n=54 participants at risk Reproxalap dosed topically prior to dry eye chamber entry	Lifitegrast n=56 participants at risk Lifitegrast dosed topically prior to dry eye chamber entry
Nervous system disorders Nervous System Disorders	0.00% 0/54 • One day for each intervention	10.7% 6/56 • Number of events 6 • One day for each intervention
General disorders General Disorders	74.1% 40/54 • Number of events 40 • One day for each intervention	10.7% 6/56 • Number of events 6 • One day for each intervention

Additional Information

Director of Clinical Trials

Aldeyra Therapeutics, Inc.

Phone: 781-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place