Reproxalap for Dry Eye Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Aldeyra Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Eligibility Criteria

This trial is for individuals with Dry Eye Disease, a condition where eyes don't produce enough tears or the right quality of tears. Participants should have a confirmed diagnosis and meet other study requirements not specified here.

Inclusion Criteria

I am 18 years old or older.

I have used or wanted to use eye drops for dry eyes in the last 6 months.

Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form

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Exclusion Criteria

I haven't taken systemic steroids or immune therapies in the last 14 days and don't plan to during the trial.

Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters

I had LASIK eye surgery less than a year ago.

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Treatment Details

Interventions

Reproxalap Ophthalmic Solution (Other)

Trial OverviewThe trial is testing the effectiveness and safety of Reproxalap Ophthalmic Solution (0.25%) compared to a placebo solution in people with Dry Eye Disease. It's set up so neither participants nor researchers know who gets the real treatment versus placebo.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive daysExperimental Treatment1 Intervention

Group II: Vehicle Ophthalmic Solution administered six times over two consecutive daysPlacebo Group1 Intervention