drugset / Trial / NCT03494504

ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

NCT03494504 ↗

Phase 3 Completed 318 enrolled Aldeyra Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis

Timeline

Start
2018-03-30
Primary completion
2018-11-05
Completion
2018-11-05

Outcome

Met primary endpoint

release “The clinical trial met the primary endpoint and the key secondary endpoint for both concentrations of reproxalap.” aldeyra.com ↗

release “In 2019, Aldeyra announced achievement of the primary endpoint of the Phase 3 ALLEVIATE Trial in allergic conjunctivitis” aldeyra.com ↗

release “Primary and key secondary endpoints in allergic conjunctivitis were previously achieved in the Phase 3 ALLEVIATE conjunctival allergen challenge trial” aldeyra.com ↗

release “In the Phase 3 ALLEVIATE Trial, 0.25% reproxalap demonstrated statistically significant reductions from vehicle” aldeyra.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Reproxalap Other / unclassified 0.25 % —
Subject Reproxalap Other / unclassified 0.5 % —

Indications