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

September 25, 2024 updated by: Azura Ophthalmics

A Phase 3, Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Efficacy, Safety, and Tolerability of AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Associated Symptoms of 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 vehicle) will be dosed twice-weekly at bedtime for up to 12 months.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Eye Center
    • California
      • Glendale, California, United States, 91204
        • Global Research Management, Inc
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation
      • Torrance, California, United States, 90505
        • NVISION Clinical Research
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Wyse Eyecare
    • Indiana
      • Columbus, Indiana, United States, 47203
        • Pankratz Eye Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • The Eye Care Institute/Butchertown Clinical Trials
    • Missouri
      • St. Louis, Missouri, United States, 63131
        • Ophthalmology Associates
    • North Carolina
      • Apex, North Carolina, United States, 27502
        • NC Eye Associates
      • Garner, North Carolina, United States, 27529
        • Oculus Research, Inc.
      • Shelby, North Carolina, United States, 28150
        • CORE
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Scott & Christie and Associates, PC
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Advancing Vision Research (AVR) - Goodlettsville
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care
      • Smyrna, Tennessee, United States, 37167
        • Advancing Vision Research (AVR) - Smyrna
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Criteria:

  • Ocular disease (except for Meibomian Gland Dysfunction (MGD) and DED/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled by the investigator.
  • Patient has glaucoma, ocular hypertension, or an intraocular pressure (IOP) of ≥24 mm Hg in either eye at Screening.
  • Recent (within the past 3 months of Screening) ocular surgery, trauma, herpes, or recurrent inflammation.
  • Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZR-MD-001
AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.
Drug: AZR-MD-001
AZR-MD-001 sterile ophthalmic ointment 0.5%
Other Names:
  • AZR-MD-001 ophthalmic ointment 0.5%
Placebo Comparator: Vehicle
AZR-MD-001 Vehicle to be administered twice weekly at bedtime.
Other: Vehicle
AZR-MD-001 Vehicle
Other Names:
  • AZR-MD-001 Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Meibomian Glands Yielding Liquid Secretion
Time Frame: Month 3
Meibomian Glands Yielding Liquid Secretion (MGYLS) measures the number of meibomian glands (0 - 15) secreting liquid
Month 3
Change from baseline in Total Ocular Surface Disease Index Score
Time Frame: Month 3
The Total Ocular Surface Disease Index Score (OSDI) provides a score from 0 (normal) to 100 (abnormal)
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azura Ophthalmics

Collaborators

ORA, Inc.

Investigators

  • Study Director: Charles Bosworth, PhD, Azura Ophthalmics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ202401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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