Reproxalap for Dry Eye Syndrome

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

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.

Exclusion Criteria

I use eye drops or gels that I'm not willing to stop during the trial.

I currently have an eye infection or inflammation.

Treatment Details

The 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.

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