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