Reproxalap for Dry Eye Syndrome

Overseen By Annalisa Webb

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Aldeyra Therapeutics, Inc.

Must not be taking: Cyclosporine, Lifitegrast, Corticosteroids, others

Disqualifiers: Ocular infection, Contact lenses, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of this trial?

A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap

Eligibility Criteria

This trial is for individuals with Dry Eye Disease, a condition where eyes do not stay properly lubricated. Participants should have a confirmed diagnosis and may need to meet other specific health criteria set by the study.

Inclusion Criteria

I have signed the consent and HIPAA forms.

I am 18 years old or older.

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

Exclusion Criteria

Use of contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial

Use of eye drops within 2 hours of Visit 1

I do not have an eye infection or inflammation right now.

Treatment Details

Interventions

• Reproxalap

Trial Overview The trial is testing the effectiveness of Reproxalap ophthalmic solution (0.25%) compared to a vehicle (placebo) solution in improving symptoms of dry eye. It's conducted at multiple centers, with participants randomly assigned to either treatment.

Participant Groups

Group I: Reproxalap Ophthalmic Solution (0.25%) Experimental Treatment 1 Intervention

Group II: Vehicle Ophthalmic Solution Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Aldeyra Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

4,700+