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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Phase 3
Waitlist Available
Research Sponsored by Aldeyra Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up safety assessment period (day 1 through day 28 or day 1 through day 360)
Awards & highlights
Pivotal Trial

Summary

This trial is testing eye drops containing Reproxalap to see if they are safe for people with dry eyes. The drops aim to reduce swelling and discomfort in the eyes. The study involves multiple centers and compares the eye drops to another treatment. Reproxalap is being tested for its safety and effectiveness in treating dry eye disease.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~safety assessment period (day 1 through day 28 or day 1 through day 360)
This trial's timeline: 3 weeks for screening, Varies for treatment, and safety assessment period (day 1 through day 28 or day 1 through day 360) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ocular treatment emergent adverse events (TEAEs)

Side effects data

From 2021 Phase 3 trial • 95 Patients • NCT04207736
6%
General disorders and administrations site conditions
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle
Reproxalap (0.25%)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for two weeks.Experimental Treatment1 Intervention
Group II: Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for 11 months.Experimental Treatment1 Intervention
Group III: Vehicle Ophthalmic Solution QID for four weeks followed by BID for two weeks.Placebo Group1 Intervention
Group IV: Vehicle Ophthalmic Solution QID for four weeks followed by BID for 11 months.Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reproxalap Ophthalmic Solution (0.25%)
2022
Completed Phase 3
~2820

Find a Location

Who is running the clinical trial?

Aldeyra Therapeutics, Inc.Lead Sponsor
33 Previous Clinical Trials
3,921 Total Patients Enrolled
~157 spots leftby Dec 2025
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