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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 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.

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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

Dry Eye Disease

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

FieldValue
Enrollment Target 500 participants
Start Date 2024-05-28
Est. Completion 2025-11
Phase Phase 3

Sponsor

Azura Ophthalmics

1 total trials

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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, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 240-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (108% higher). The listed sponsor is Azura Ophthalmics, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.