A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
NCT ID: NCT06329791
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2024-05-28
2025-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZR-MD-001
AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.
AZR-MD-001
AZR-MD-001 sterile ophthalmic ointment 0.5%
Vehicle
AZR-MD-001 Vehicle to be administered twice weekly at bedtime.
Vehicle
AZR-MD-001 Vehicle
Interventions
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AZR-MD-001
AZR-MD-001 sterile ophthalmic ointment 0.5%
Vehicle
AZR-MD-001 Vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of active Evaporative DED at Screening and Baseline.
* Evidence of meibomian gland obstruction in both eyes at Screening and Baseline.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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ORA, Inc.
INDUSTRY
Azura Ophthalmics
INDUSTRY
Responsible Party
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Principal Investigators
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Charles Bosworth, PhD
Role: STUDY_DIRECTOR
Azura Ophthalmics
Locations
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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
Countries
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Other Identifiers
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AZ202401
Identifier Type: -
Identifier Source: org_study_id
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