The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

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

Timeline

Start

2021-08-28

Primary completion

2022-03-04

Completion

2022-03-04

Outcome

Met primary endpoint

registry analysis (superiority test); Reproxalap vs Vehicle; p <0.0001; Odds Ratio (OR) 2.63 (95% CI 1.67 to 4.13); Generalized estimating equation NCT05062330 ↗

release “Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the achievement of the primary endpoint in the Phase 3 TRANQUILITY-2 clinical trial (TRANQUILITY-2) of reproxalap” aldeyra.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reproxalap	Other / unclassified	0.25 %	Other

Indications