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

NCT06329791 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: AZ202401
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 16

Brief 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

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Meibomian Glands Yielding Liquid Secretion

  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

  The Total Ocular Surface Disease Index Score (OSDI) provides a score from 0 (normal) to 100 (abnormal)

  Month 3

Study Arms (2)

AZR-MD-001

EXPERIMENTAL

AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.

Drug: AZR-MD-001

Vehicle

PLACEBO COMPARATOR

AZR-MD-001 Vehicle to be administered twice weekly at bedtime.

Other: Vehicle

Interventions

AZR-MD-001 DRUG

AZR-MD-001 sterile ophthalmic ointment 0.5%

Also known as: AZR-MD-001 ophthalmic ointment 0.5%

AZR-MD-001

Vehicle OTHER

AZR-MD-001 Vehicle

Also known as: AZR-MD-001 Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azura Ophthalmics: lead
• ORA, Inc.: collaborator

Study Sites (16)

Arizona Eye Center

Chandler, Arizona, 85225, United States

Location

Global Research Management, Inc

Glendale, California, 91204, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

NVISION Clinical Research

Torrance, California, 90505, United States

Location

Wyse Eyecare

Northbrook, Illinois, 60062, United States

Location

Pankratz Eye Institute

Columbus, Indiana, 47203, United States

Location

The Eye Care Institute/Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

NC Eye Associates

Apex, North Carolina, 27502, United States

Location

Oculus Research, Inc.

Garner, North Carolina, 27529, United States

Location

CORE

Shelby, North Carolina, 28150, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Advancing Vision Research (AVR) - Goodlettsville

Goodlettsville, Tennessee, 37072, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research (AVR) - Smyrna

Smyrna, Tennessee, 37167, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Charles Bosworth, PhD

  Azura Ophthalmics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: May 28, 2024
• Primary Completion: December 1, 2024
• Study Completion: November 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)