drugset / Trial / NCT06329791

A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)

NCT06329791 ↗

Phase 3 Unknown 500 enrolled Azura Ophthalmics ORA, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.

Timeline

Start
2024-05-28
Primary completion
2024-12
Completion
2025-11

Drugs

EvaluationDrugModalityDoseRoute
Subject AZR-MD-001 Unknown 0.5 % Topical

Indications