AZR-MD-001 for Dry Eye Syndrome

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Azura Ophthalmics

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This clinical trial is for individuals with abnormal meibomian gland function leading to Dry Eye Disease (DED). Specific details about who can join or reasons why someone might not be able to participate are not provided.

Inclusion Criteria

Evidence of meibomian gland obstruction in both eyes at Screening and Baseline

I have been diagnosed with active Evaporative Dry Eye Disease.

I am 18 years old or older.

Exclusion Criteria

My eye condition is under control, except for dry eyes or MGD.

I have glaucoma, high eye pressure, or my eye pressure is 24 mm Hg or higher.

I am not willing to stop my current treatments for dry eye during the study.

+1 more

Participant Groups

The study compares the effects of an ointment called AZR-MD-001 against a placebo (vehicle) in treating dry eye symptoms. Participants will use their assigned treatment at bedtime twice a week for up to one year, and the process is double-masked so neither participants nor researchers know who gets which treatment.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AZR-MD-001Experimental Treatment1 Intervention

AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.

Group II: VehiclePlacebo Group1 Intervention

AZR-MD-001 Vehicle to be administered twice weekly at bedtime.