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

Status unconfirmed · Phase 3

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT06329791

Run by

Azura Ophthalmics

People needed

500

Starts

2024-05-28

Expected to finish

2025-11-01

Last updated by the study team

2024-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 years of age or older at Screening.
• Evidence of active Evaporative DED at Screening and Baseline.
• Evidence of meibomian gland obstruction in both eyes at Screening and Baseline.

You may not qualify if…

• Ocular disease (except for Meibomian Gland Dysfunction (MGD) and DED/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled by the investigator.
• Patient has glaucoma, ocular hypertension, or an intraocular pressure (IOP) of ≥24 mm Hg in either eye at Screening.
• Recent (within the past 3 months of Screening) ocular surgery, trauma, herpes, or recurrent inflammation.
• Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration.

Where it is running

• Arizona Eye Center — Chandler, Arizona, United States
• Global Research Management, Inc — Glendale, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• NVISION Clinical Research — Torrance, California, United States
• Wyse Eyecare — Northbrook, Illinois, United States
• Pankratz Eye Institute — Columbus, Indiana, United States
• The Eye Care Institute/Butchertown Clinical Trials — Louisville, Kentucky, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• NC Eye Associates — Apex, North Carolina, United States
• Oculus Research, Inc. — Garner, North Carolina, United States
• CORE — Shelby, North Carolina, United States
• Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States
• Advancing Vision Research (AVR) - Goodlettsville — Goodlettsville, Tennessee, United States
• Total Eye Care — Memphis, Tennessee, United States
• Advancing Vision Research (AVR) - Smyrna — Smyrna, Tennessee, United States
• Piedmont Eye Center — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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