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NCT06329791 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
A Phase 3 study of Dry Eye Disease, sponsored by Azura Ophthalmics.
- Active
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 16
- Study locations
NCT06329791: Active Phase 3 study of Dry Eye Disease, sponsored by Azura Ophthalmics.
NCT06329791 is a Phase 3 study of Dry Eye Disease that is active but no longer recruiting, run by Azura Ophthalmics. The registered enrollment target is 500 participants, above the 240-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (108% higher). The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06329791, a Phase 3 study of Dry Eye Disease, is active but no longer recruiting, sponsored by Azura Ophthalmics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 16
- Study locations
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 |
What the registry record for NCT06329791 still lists
NCT06329791 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 240-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (108% higher).
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.
NCT06329791 lists 16 locations in 10 states (California, North Carolina, Tennessee).
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.
What interventions are being tested in trial NCT06329791?
The interventions under investigation include: Vehicle (OTHER), AZR-MD-001 (DRUG).
Who is sponsoring clinical trial NCT06329791?
This trial is sponsored by Azura Ophthalmics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Dry Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06329791's enrollment target sits among peer trials
500 4th of 33 higher than 30 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Clinical Study to Evaluate the Effect and Side Effect of a New Artificial Tear Formulation (ABBV-444) Compared to Refresh Optive Unit Dose in Adult Participants With Dry Eye Disease
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-
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