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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

Study 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.Check my eligibility
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.See study design
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

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

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.

Find a Location

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
8,452 Total Patients Enrolled
Charles Bosworth, PhDStudy DirectorAzura Ophthalmics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the safety implications of AZR-MD-001 for individuals?

"Based on the evaluation by our research team at Power, we have assigned a safety rating of 3 to AZR-MD-001. This assessment is informed by the Phase 3 trial status, indicating existing efficacy data and robust safety evidence from multiple iterations."

Answered by AI

Are patients currently eligible to participate in this ongoing clinical trial?

"As per clinicaltrials.gov, the ongoing recruitment of participants for this particular trial has ceased. The initial posting date was May 1st, 2024 and the most recent update occurred on March 19th, 2024. Despite this specific study no longer seeking volunteers, it is important to note that there are currently 133 alternative studies actively enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
2024. "A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06329791.
All > Dry Eye
~333 spots leftby Dec 2024
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