protocolSection identificationModule nctId: NCT06329791, orgStudyIdInfo id: AZ202401, briefTitle: A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Azura Ophthalmics, class: INDUSTRY, collaborators name: ORA, Inc., descriptionModule briefSummary: 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., conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: AZR-MD-001, interventions name: Vehicle, outcomesModule primaryOutcomes measure: Change from baseline in Meibomian Glands Yielding Liquid Secretion, primaryOutcomes measure: Change from baseline in Total Ocular Surface Disease Index Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arizona Eye Center, city: Chandler, state: Arizona, zip: 85225, country: United States, contacts name: Erin Fox, role: CONTACT, phone: 714-559-8435, email: michael.depenbusch@doctrials.com, geoPoint lat: 33.30616, lon: -111.84125, locations facility: Global Research Management, Inc, city: Glendale, state: California, zip: 91204, country: United States, contacts name: Logi El-Harazi, role: CONTACT, email: logi@grmclinical.com, geoPoint lat: 34.14251, lon: -118.25508, locations facility: Eye Research Foundation, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: Linda Wirta, role: CONTACT, email: linda.wirta@drwirta.com, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Pankratz Eye Institute, city: Columbus, state: Indiana, zip: 47203, country: United States, contacts name: Kristin Slevin, role: CONTACT, email: Kslevin@pankratzeye.com, geoPoint lat: 39.20144, lon: -85.92138, locations facility: The Eye Care Institute/Butchertown Clinical Trials, city: Louisville, state: Kentucky, zip: 40206, country: United States, contacts name: Danielle Gulock, role: CONTACT, email: dgulock@eyecareinstitute.com, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Ophthalmology Associates, city: Saint Louis, state: Missouri, zip: 63131, country: United States, contacts name: Maggie Thompson, role: CONTACT, email: maggiethompson@eyecare-partners.com, geoPoint lat: 38.62727, lon: -90.19789, locations facility: NC Eye Associates, city: Apex, state: North Carolina, zip: 27502, country: United States, contacts name: Ashley Cooper, role: CONTACT, email: acooper@nceyeassociates.com, geoPoint lat: 35.73265, lon: -78.85029, locations facility: Oculus Research, Inc., city: Garner, state: North Carolina, zip: 27529, country: United States, geoPoint lat: 35.71126, lon: -78.61417, locations facility: CORE, city: Shelby, state: North Carolina, zip: 28150, country: United States, contacts name: Winnie Simmons, role: CONTACT, email: winniesimmons.core@gmail.com, geoPoint lat: 35.29235, lon: -81.53565, locations facility: Scott & Christie and Associates, PC, city: Cranberry Township, state: Pennsylvania, zip: 16066, country: United States, geoPoint lat: 40.68496, lon: -80.10714, locations facility: Advancing Vision Research (AVR) - Goodlettsville, city: Goodlettsville, state: Tennessee, zip: 37072, country: United States, contacts name: Megan Medlin, role: CONTACT, email: meganm@avrteam.com, geoPoint lat: 36.32311, lon: -86.71333, locations facility: Total Eye Care, city: Memphis, state: Tennessee, zip: 38119, country: United States, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Advancing Vision Research (AVR) - Smyrna, city: Smyrna, state: Tennessee, zip: 37167, country: United States, contacts name: Megan Medlin, role: CONTACT, email: meganm@avrteam.com, geoPoint lat: 35.98284, lon: -86.5186, locations facility: Piedmont Eye Center, city: Lynchburg, state: Virginia, zip: 24502, country: United States, contacts name: Jennifer Frederick, role: CONTACT, email: jfrederick@piedmonteye.com, geoPoint lat: 37.41375, lon: -79.14225, hasResults: False