CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 329 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/NCT04674358
NCT04674358Phase 3Completed

The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 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 Dec 19, 2020·Updated Mar 19, 2025

In Brief

A Phase 3 clinical trial evaluating Reproxalap Ophthalmic Solution (0.25%) and Vehicle Opthalmic Solution for Dry Eye and Dry Eye Syndromes. Completed, enrolled 329 participants across 1 site.

Detailed Summary

The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 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--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 19, 2020
Enrollment StartNov 21, 2020
Primary CompletionSep 12, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.5 years ago

Interventions

Reproxalap Ophthalmic Solution (0.25%)drug

Reproxalap Ophthalmic Solution (0.25%) administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).

Vehicle Opthalmic Solutiondrug

Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).