CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 757 enrolled
Drug / intervention
Reproxalap Ophthalmic Solution (0.25%) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04735393
NCT04735393Phase 3Completed
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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Aldeyra Therapeutics, Inc.·interventional·Posted Feb 3, 2021·Updated Nov 26, 2025

In Brief

A Phase 3 clinical trial evaluating Reproxalap Ophthalmic Solution (0.25%) and Placebo Comparator for Dry Eye Disease. Completed, enrolled 757 participants across 1 site.

Detailed Summary

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 3, 2021
Enrollment StartJan 26, 2021
Primary CompletionOct 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.4 years ago

Interventions

Reproxalap Ophthalmic Solution (0.25%)drug

Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).

Placebo Comparatordrug

Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).

Reproxalap Ophthalmic Solution (0.25%)drug

Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).

Placebo Comparatordrug

Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).