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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 day 2
Awards & highlights

Study Summary

This study is evaluating whether a drug called Reproxalap can improve symptoms of dry eye disease.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Schirmer's Test greater than or equal to 10mm (millimeter) responder analysis of change from baseline.
Schirmer's Test overall mean change from baseline
Secondary outcome measures
Erythema

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive daysExperimental Treatment1 Intervention
Group II: Vehicle Ophthalmic Solution administered 7 times over two consecutive daysPlacebo 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
3,672 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
2021. "The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05062330.
~101 spots leftby Apr 2025
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