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

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.

Timeline

Start

2020-11-21

Primary completion

2021-09-12

Completion

2021-09-12

Outcome

Missed primary endpoint

release “Although the primary endpoint of ocular redness was not met in TRANQUILITY” aldeyra.com ↗

release “As previously announced, the Phase 3 TRANQUILITY trial failed to meet the primary endpoint of ocular redness as assessed by independent central reviewers.” aldeyra.com ↗

Drugs

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

Indications