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A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
Sponsor: Azura Ophthalmics
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-05-28
Completion Date
2025-11
Last Updated
2024-09-27
Healthy Volunteers
No
Conditions
Interventions
AZR-MD-001
AZR-MD-001 sterile ophthalmic ointment 0.5%
Vehicle
AZR-MD-001 Vehicle
Locations (16)
Arizona Eye Center
Chandler, Arizona, United States
Global Research Management, Inc
Glendale, California, United States
Eye Research Foundation
Newport Beach, California, United States
NVISION Clinical Research
Torrance, 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
CORE
Shelby, North Carolina, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Advancing Vision Research (AVR) - Goodlettsville
Goodlettsville, Tennessee, United States
Total Eye Care
Memphis, Tennessee, United States
Advancing Vision Research (AVR) - Smyrna
Smyrna, Tennessee, United States
Piedmont Eye Center
Lynchburg, Virginia, United States