CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 422 enrolled
Drug / intervention
Reproxalap Ophthalmic Solution (0.25%) QID +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/NCT03879863
NCT03879863Phase 3Completed

The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Aldeyra Therapeutics, Inc.·interventional·Posted Mar 19, 2019·Updated Jan 23, 2025

In Brief

A Phase 3 clinical trial evaluating Reproxalap Ophthalmic Solution (0.25%) QID, Vehicle Ophthalmic Solution QID, and 2 other interventions for Dry Eye. Completed, enrolled 422 participants across 1 site.

Detailed Summary

The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Study Details

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

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 19, 2019
Enrollment StartApr 16, 2019
Primary CompletionOct 4, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.3 years ago

Interventions

Reproxalap Ophthalmic Solution (0.25%) QIDdrug

Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks

Vehicle Ophthalmic Solution QIDdrug

Vehicle Ophthalmic Solution administered QID for twelve weeks

Reproxalap Ophthalmic Solution (0.25%) QID to BIDdrug

Reproxalap Ophthalmic Solution (0.25%) administered QID for four weeks, followed by BID administration for eight weeks

Vehicle Ophthalmic Solution QID to BIDdrug

Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks