drugset / Trial / NCT03131154

SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

NCT03131154 ↗

Phase 3 Completed 123 enrolled Aldeyra Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.

Timeline

Start
2017-04-26
Primary completion
2019-04-19
Completion
2019-04-26

Outcome

Missed primary endpoint

registry Hazard Ratio (HR) 1.129 (95% CI 0.643 to 1.982) NCT03131154 ↗

release “today announced results from the noninfectious anterior uveitis SOLACE Trial. Statistical significance was not achieved for the primary or secondary endpoints” aldeyra.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Reproxalap Other / unclassified 0.5 % —