A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)

Last updated: September 25, 2024
Sponsor: Azura Ophthalmics
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dry Eyes

Sjogren's Syndrome

Dry Eye Disease

Treatment

AZR-MD-001

Vehicle

Clinical Study ID

NCT06329791
AZ202401
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, 18 years of age or older at Screening.

  • Evidence of active Evaporative DED at Screening and Baseline.

  • Evidence of meibomian gland obstruction in both eyes at Screening and Baseline.

Exclusion

Exclusion Criteria:

  • Ocular disease (except for Meibomian Gland Dysfunction (MGD) andDED/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled bythe investigator.

  • Patient has glaucoma, ocular hypertension, or an intraocular pressure (IOP) of ≥24mm Hg in either eye at Screening.

  • Recent (within the past 3 months of Screening) ocular surgery, trauma, herpes, orrecurrent inflammation.

  • Unwilling to abstain from the use of systemic or topical treatments for MGD or dryeye for the study duration.

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: AZR-MD-001
Phase: 3
Study Start date:
May 28, 2024
Estimated Completion Date:
November 30, 2025

Study Description

This study is 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.

Following a Screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio.

Study follow-up visits will be conducted on Day 14, Month 1.5, Month 3, Month 4.5, Month 6, Month 9, and Month 12. Patients will exit the study approximately 13 months after the Baseline visit. Any ongoing treatment-emergent adverse events (TEAEs) will be followed for an additional 30 days following the Month 12 visit.

Connect with a study center

  • Arizona Eye Center

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Global Research Management, Inc

    Glendale, California 91204
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • NVISION Clinical Research

    Torrance, California 90505
    United States

    Site Not Available

  • Wyse Eyecare

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • Pankratz Eye Institute

    Columbus, Indiana 47203
    United States

    Site Not Available

  • The Eye Care Institute/Butchertown Clinical Trials

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Ophthalmology Associates

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Ophthalmology Associates

    St. Louis, Missouri 63131
    United States

    Site Not Available

  • NC Eye Associates

    Apex, North Carolina 27502
    United States

    Site Not Available

  • Oculus Research, Inc.

    Garner, North Carolina 27529
    United States

    Site Not Available

  • CORE

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania 16066
    United States

    Active - Recruiting

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Advancing Vision Research (AVR) - Goodlettsville

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Total Eye Care

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Advancing Vision Research (AVR) - Smyrna

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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