A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
- Registration Number
- NCT06329791
- Lead Sponsor
- Azura Ophthalmics
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle AZR-MD-001 Vehicle to be administered twice weekly at bedtime. AZR-MD-001 AZR-MD-001 AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.
- Primary Outcome Measures
Name Time Method Change from baseline in Meibomian Glands Yielding Liquid Secretion Month 3 Meibomian Glands Yielding Liquid Secretion (MGYLS) measures the number of meibomian glands (0 - 15) secreting liquid
Change from baseline in Total Ocular Surface Disease Index Score Month 3 The Total Ocular Surface Disease Index Score (OSDI) provides a score from 0 (normal) to 100 (abnormal)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
CORE
🇺🇸Shelby, North Carolina, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
NVISION Clinical Research
🇺🇸Torrance, California, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Global Research Management, Inc
🇺🇸Glendale, California, United States
Wyse Eyecare
🇺🇸Northbrook, Illinois, United States
Pankratz Eye Institute
🇺🇸Columbus, Indiana, United States
The Eye Care Institute/Butchertown Clinical Trials
🇺🇸Louisville, Kentucky, United States
Ophthalmology Associates
🇺🇸St. Louis, Missouri, United States
NC Eye Associates
🇺🇸Apex, North Carolina, United States
Oculus Research, Inc.
🇺🇸Garner, North Carolina, United States
Advancing Vision Research (AVR) - Goodlettsville
🇺🇸Goodlettsville, Tennessee, United States
Total Eye Care
🇺🇸Memphis, Tennessee, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Advancing Vision Research (AVR) - Smyrna
🇺🇸Smyrna, Tennessee, United States