CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 206 enrolled
Drug / intervention
Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID +1 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/NCT03916042
NCT03916042Phase 2Completed

A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects With Dry Eye Disease

Aldeyra Therapeutics, Inc.·interventional·Posted Apr 16, 2019·Updated Mar 3, 2025

In Brief

A Phase 2 clinical trial evaluating Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID and Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID for Dry Eye. Completed, enrolled 206 participants across 1 site.

Detailed Summary

A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects with Dry Eye Disease

Study Details

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

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 16, 2019
Enrollment StartApr 23, 2019
Primary CompletionNov 22, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.2 years ago

Interventions

Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BIDdrug

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

Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BIDdrug

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