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A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
NCT06329791 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Vehicle
- DRUG AZR-MD-001
Study Locations (16)
California
- Global Research Management, Inc — Glendale
- Eye Research Foundation — Newport Beach
- NVISION Clinical Research — Torrance
North Carolina
- NC Eye Associates — Apex
- Oculus Research, Inc. — Garner
- CORE — Shelby
Tennessee
- Advancing Vision Research (AVR) - Goodlettsville — Goodlettsville
- Total Eye Care — Memphis
- Advancing Vision Research (AVR) - Smyrna — Smyrna
Arizona
- Arizona Eye Center — Chandler
Illinois
- Wyse Eyecare — Northbrook
Indiana
- Pankratz Eye Institute — Columbus
Kentucky
- The Eye Care Institute/Butchertown Clinical Trials — Louisville
Missouri
- Ophthalmology Associates — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-05-28 |
| Est. Completion | 2025-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06329791
The ClinicalTrials.gov registry entry for NCT06329791 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Azura Ophthalmics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions — of which Vehicle is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06329791 reports 16 study locations spanning 10 distinct geographic areas — top geographies include California, North Carolina, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06329791 about?
NCT06329791 is a clinical study titled "A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)". 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 ve...
What is the current status of trial NCT06329791?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2024-05-28. Estimated completion is 2025-11.
What conditions does trial NCT06329791 study?
This clinical trial studies the following conditions: Dry Eye Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06329791?
The interventions under investigation include: Vehicle (OTHER), AZR-MD-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06329791?
This trial is sponsored by Azura Ophthalmics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06329791 being conducted?
This trial has 16 study locations across Arizona, California, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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