A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

NCT03652051 ↗

Phase 2 Completed 321 enrolled Azura Ophthalmics Cliantha Research · collab Syneos Health · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Timeline

Start: 2018-09-10
Primary completion: 2022-09-14
Completion: 2022-10-19

Outcome

Met primary endpoint

paper Co-primary endpoints were met for AZR-MD-001 0.5% at Month 3 PMID 37478969 ↗

release “study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD). The trial met its co-primary endpoints” azuraophthalmics.com ↗

Publications

Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, Alster Y, Bosworth C, Rafaeli O, DePuy V; CELESTIAL STUDY Group. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-546. doi: 10.1016/j.jtos.2023.07.002. Epub 2023 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	selenium sulfide	Small molecule	0.5 %	Topical
Subject	selenium sulfide	Small molecule	1 %	Topical