Reproxalap for Dry Eye Syndrome

Overseen By Bill Cavanagh

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Aldeyra Therapeutics, Inc.

Must not be taking: Systemic corticosteroids, Immunomodulators

Disqualifiers: Blepharitis, 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: 2

Duration: 2 days

110 Participants Needed

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.

Inclusion Criteria

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

I have had dry eye discomfort for at least 6 months.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either Reproxalap Ophthalmic Solution or Vehicle Ophthalmic Solution six times over two consecutive days

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Reproxalap Ophthalmic Solution

Trial Overview 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.

Participant Groups

Group I: Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days Experimental Treatment 1 Intervention

Group II: Vehicle Ophthalmic Solution administered six times over two consecutive days Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Aldeyra Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

4,700+