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Reproxalap Ophthalmic Solution (0.25%) for Dry Eye Syndrome

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

Study Summary

This study is evaluating whether a new eye drop may help improve 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ocular treatment emergent adverse events (TEAEs)

Side effects data

From 2021 Phase 2 trial • 158 Patients • NCT04971031
4%
General disorders and administration site conditions
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle
Reproxalap (0.25%)

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
~2690

Find a Location

Who is running the clinical trial?

Aldeyra Therapeutics, Inc.Lead Sponsor
29 Previous Clinical Trials
3,276 Total Patients Enrolled

Frequently Asked Questions

~182 spots leftby Apr 2025