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AZR-MD-001 for Dry Eye Syndrome

Phase 3
Waitlist Available
Research Sponsored by Azura Ophthalmics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
Pivotal Trial

Summary

This trial will test a new ointment to treat a common eye condition called meibomian gland dysfunction. Participants will either receive the new ointment or a placebo, and will apply it

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not listed, but as with any eye ointment, there could be risks such as eye irritation, discomfort, redness, or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Meibomian Glands Yielding Liquid Secretion
Change from baseline in Total Ocular Surface Disease Index Score

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

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Who is running the clinical trial?

Azura OphthalmicsLead Sponsor
5 Previous Clinical Trials
477 Total Patients Enrolled
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,459 Total Patients Enrolled
Charles Bosworth, PhDStudy DirectorAzura Ophthalmics
~0 spots leftby Dec 2024
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