CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 361 enrolled
Drug / intervention
Reproxalap Ophthalmic Solution (0.25%) +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/NCT05062330
NCT05062330Phase 3Completed

The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Aldeyra Therapeutics, Inc.·interventional·Posted Sep 30, 2021·Updated Mar 18, 2025

In Brief

A Phase 3 clinical trial evaluating Reproxalap Ophthalmic Solution (0.25%) and Vehicle Ophthalmic Solution for Dry Eye. Completed, enrolled 361 participants across 1 site.

Detailed Summary

The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap 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
20222023202420252026
First PostedSep 30, 2021
Enrollment StartAug 28, 2021
Primary CompletionMar 4, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.8 years ago

Interventions

Reproxalap Ophthalmic Solution (0.25%)drug

Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days

Vehicle Ophthalmic Solutiondrug

Vehicle Ophthalmic Solution administered 7 times over two consecutive days