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

Phase 2

Completed

Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Vehicle Ophthalmic Solution

Brief Summary: A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Recruitment & Eligibility

Inclusion Criteria

Eighteen (18) to 70 years of age at the time of screening (either gender and any race)
Ability to provide written informed consent
Reported history of dry eye for at least 6 months prior to screening
Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening

Exclusion Criteria

Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening
Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
Women of childbearing potential (WOCBP) who are pregnant and nursing
If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
Known allergy and/or sensitivity to reproxalap or the drug product vehicle
A condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial
Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber	The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.	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.
Schirmer Test Mean Change From Baseline	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.

Secondary Outcome Measures