Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
- Registration Number
- NCT05397600
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 684
- Informed consent dated and signed.
- Both eyes diagnosed open-angle glaucoma or ocular hypertension
- History of trauma, infection, clinically significant inflammation within the previous 3 months
- Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
- Pregnancy or breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T4032 Bimatoprost Ophthalmic - Lumigan Bimatoprost Ophthalmic -
- Primary Outcome Measures
Name Time Method Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP. up to Week12 Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (63)
Scheie Eye Institute - University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Santa Barbara Eyecare - Santa Barbara
🇺🇸Santa Barbara, California, United States
Ocala Eye - 3130 Location
🇺🇸Ocala, Florida, United States
Walman Eye Center - Sun City
🇺🇸Sun City, Arizona, United States
Clinique Bellevue - Laval
🇨🇦Laval, Quebec, Canada
Houston Eye Associates (HEA) - Gramercy Location
🇺🇸Houston, Texas, United States
Indiana University School of Medicine - Eugene and Marilyn Glick Eye Institute
🇺🇸Indianapolis, Indiana, United States
Houston Eye Associates - North Loop
🇺🇸Houston, Texas, United States
Rashid, Rice, Flynn & Reilly Eye Associates - San Antonio Clinic
🇺🇸San Antonio, Texas, United States
Arizona Glaucoma Specialists - Phoenix
🇺🇸Phoenix, Arizona, United States
Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus
🇺🇸Nashville, Tennessee, United States
Eye Physicians & Surgeons of Arizona - Glendale Office
🇺🇸Glendale, Arizona, United States
Arizona Eye Center - Chandler
🇺🇸Chandler, Arizona, United States
Velvet Clinical Research
🇺🇸Burbank, California, United States
Specialty Eye Care Medical Center - Glendale
🇺🇸Glendale, California, United States
Global Research Management, Inc.
🇺🇸Glendale, California, United States
Inland Eye Specialists - Hemet
🇺🇸Hemet, California, United States
Diabetic Eye Medical Clinic - Inglewood
🇺🇸Inglewood, California, United States
Global Vision Eye Care - Los Angeles- Rock Central
🇺🇸Los Angeles, California, United States
Lakeside Vision Center - Irvine
🇺🇸Irvine, California, United States
Sage Eyecare
🇺🇸Los Angeles, California, United States
California Eye Specialists Medical Group Inc. - Monrovia
🇺🇸Monrovia, California, United States
Aesthetic Eye Care Institute - Eye Research Foundation
🇺🇸Newport Beach, California, United States
OC Surgical Eye Institute
🇺🇸Santa Ana, California, United States
North Valley Eye Medical Group, Inc.
🇺🇸Mission Hills, California, United States
Foothill Eye Institute - Pasadena
🇺🇸Pasadena, California, United States
California Eye Specialists Medical Group Inc. - Redlands
🇺🇸Redlands, California, United States
North Bay Eye Associates - Petaluma - 104 Lynch Creek Way
🇺🇸Petaluma, California, United States
ICON Eye Care - Grand Junction
🇺🇸Grand Junction, Colorado, United States
Wolstan & Goldberg Eye Associates
🇺🇸Torrance, California, United States
Nature Coast Clinical Research - Crystal River
🇺🇸Crystal River, Florida, United States
East Coast Institute for Research - Jacksonville
🇺🇸Jacksonville, Florida, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Bascom Palmer Eye Institute - University of Miami Health System - Palm Beach Gardens
🇺🇸Palm Beach Gardens, Florida, United States
Coastal Research Associates, LLC. - Atlanta
🇺🇸Roswell, Georgia, United States
Great Lakes Eye Care - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Huron Ophthalmology, P.C.
🇺🇸Ypsilanti, Michigan, United States
Fraser Eye Care Center - Fraser
🇺🇸Fraser, Michigan, United States
NV Eye Surgery - Henderson
🇺🇸Henderson, Nevada, United States
Comprehensive Eye Care, Ltd.
🇺🇸Washington, Missouri, United States
Rochester Ophthalmological Group, PC - Brighton
🇺🇸Rochester, New York, United States
"Clinic-LJ" Ltd
🇺🇸Winston-Salem, North Carolina, United States
Cincinnati Eye Institute - Blue Ash
🇺🇸Cincinnati, Ohio, United States
Abrams Eye Center, Inc.
🇺🇸Cleveland, Ohio, United States
AMA Eye Research Institute
🇺🇸Marysville, Ohio, United States
Advancing Vision Research - Goodlettsville
🇺🇸Goodlettsville, Tennessee, United States
Scott & White Cancer Center - Killeen
🇺🇸Cranberry Township, Pennsylvania, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Legacy Pulmonary Medical Group - Good Samaritan Medical Center
🇺🇸Portland, Oregon, United States
Total Eye Care, P.A.
🇺🇸Memphis, Tennessee, United States
Southwest Eye Institute
🇺🇸El Paso, Texas, United States
Texan Eye - Austin - Main Central
🇺🇸Austin, Texas, United States
Piedmont Eye Center - Lynchburg
🇺🇸Lynchburg, Virginia, United States
San Antonio Eye Center, P.A. - McCullough Ave
🇺🇸San Antonio, Texas, United States
St. George Eye Center - St. George
🇺🇸Saint George, Utah, United States
Specialty Eye Care Center - Bellevue
🇺🇸Bellevue, Washington, United States
Prism Eye Institute - Oakville
🇨🇦Oakville, Ontario, Canada
Clínica Oftalmológica del Caribe
🇨🇴Barranquilla, Colombia
Clinica de Oftalmologia de Cali SA
🇨🇴Cali, Colombia
Fundación Oftalmológica Nacional (FUNDONAL)
🇨🇴Bogotá, Colombia
Clinica de Oftalmologia Sandiego
🇨🇴Medellín, Colombia
Fundación Oftalmológica de Santander FOSCAL
🇨🇴Floridablanca, Colombia
Instituto Nacional de Investigacion en Oftalmologia
🇨🇴Medellin, Colombia