AZR-MD-001 for Dry Eye Syndrome

Recruiting at 17 trial locations

Overseen By Charles Bosworth, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Azura Ophthalmics

Must not be taking: MGD treatments, Dry eye treatments

Disqualifiers: Glaucoma, Ocular hypertension, Recent surgery, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 12 months

500 Participants Needed

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.

Will I have to stop taking my current medications?

Yes, you will need to stop using any systemic or topical treatments for Meibomian Gland Dysfunction (MGD) or dry eye during the study.

Research Team

Charles Bosworth, PhD

Principal Investigator

Azura Ophthalmics

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZR-MD-001 or vehicle twice weekly at bedtime for up to 12 months

12 months

Visits on Day 14, Month 1.5, Month 3, Month 4.5, Month 6, Month 9, and Month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, with ongoing TEAEs followed for an additional 30 days

1 month

Treatment Details

Interventions

• AZR-MD-001
• Vehicle

Trial Overview 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.

Participant Groups

Group I: AZR-MD-001 Experimental Treatment 1 Intervention

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

Group II: Vehicle Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Azura Ophthalmics

Lead Sponsor

Trials

6

Recruited

980+

ORA, Inc.

Industry Sponsor

Trials

72

Recruited

9,200+

Stuart Abelson

ORA, Inc.

Chief Executive Officer since 2007

BSc in Neuroscience from Bates College, MBA from Northwestern University

Dr. Gustavo De Moraes

ORA, Inc.

Chief Medical Officer since 2022

MD, PhD in Ophthalmic Sciences, MPH in Biostatistics