Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)

Summary

A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.

Timeline

Start

2022-11-10

Primary completion

2023-10-13

Completion

2023-10-13

Outcome

Met primary endpoint

release “Study met its primary endpoint and showed significant and clinically meaningful improvements in multiple symptoms of Contact Lens Discomfort” azuraophthalmics.com ↗

release “The FDA confirmed the CELESTIAL and ARIES study data fulfill the regulatory efficacy requirements for approvability of AZR-MD-001” azuraophthalmics.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZR-MD-001	Unknown	1 %	—

Indications