NCT05397600CompletedPhase 3
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Source: ClinicalTrials.gov · Last updated 18 Jul 2024
Brief summary (registry, in English)
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 684 (actual)
- First submitted
- 25 May 2022
- Start date
- 22 Jun 2022
- Primary completion date
- 7 Mar 2024
- Lead sponsor
- Laboratoires Thea
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT05397600
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 684
- From 22 Jun 2022 to the primary completion date, 7 Mar 2024
- 63 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of trauma, infection, clinically significant inflammation within the previous 3 months
Other illness
- Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
Other
- Pregnancy or breast-feeding
Who the study is looking for
- Informed consent dated and signed.
- Both eyes diagnosed open-angle glaucoma or ocular hypertension
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (63)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Bellevue - Laval Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| Prism Eye Institute - Oakville Coordinator of this site? Confirm its status | Oakville | Canada | Unknown status |
| Clinica Oftalmologica del Caribe Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Fundación Oftalmológica Nacional (FUNDONAL) Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Clinica de Oftalmologia de Cali SA Coordinator of this site? Confirm its status | Cali | Colombia | Unknown status |
| Fundacion Oftalmologica de Santander - FOSCAL Coordinator of this site? Confirm its status | Floridablanca | Colombia | Unknown status |
| Clinica de Oftalmologia Sandiego Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Instituto Nacional de Investigacion en Oftalmologia Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Texan Eye - Austin - Main Central Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Specialty Eye Care Center - Bellevue Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Velvet Clinical Research Coordinator of this site? Confirm its status | Burbank | United States | Unknown status |
| Arizona Eye Center - Chandler Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Cincinnati Eye Institute - Blue Ash Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Abrams Eye Center, Inc. Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Scott & White Cancer Center - Killeen Coordinator of this site? Confirm its status | Cranberry Township | United States | Unknown status |
| Nature Coast Clinical Research - Crystal River Coordinator of this site? Confirm its status | Crystal River | United States | Unknown status |
| Southwest Eye Institute Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Fraser Eye Care Center - Fraser Coordinator of this site? Confirm its status | Fraser | United States | Unknown status |
| Specialty Eye Care Medical Center - Glendale Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Global Research Management, Inc Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Eye Physicians & Surgeons of Arizona - Glendale Office Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Advancing Vision Research - Goodlettsville Coordinator of this site? Confirm its status | Goodlettsville | United States | Unknown status |
| ICON Eye Care - Grand Junction Coordinator of this site? Confirm its status | Grand Junction | United States | Unknown status |
| Inland Eye Specialists - Hemet Coordinator of this site? Confirm its status | Hemet | United States | Unknown status |
| NV Eye Surgery - Henderson Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Houston Eye Associates (HEA) - Gramercy Location Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Houston Eye Associates, North Loop Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University School of Medicine - Eugene and Marilyn Glick Eye Institute Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Diabetic Eye Medical Clinic - Inglewood Coordinator of this site? Confirm its status | Inglewood | United States | Unknown status |
| Lakeside Vision Center - Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| East Coast Institute for Research, Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Sage Eyecare Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Global Vision Eye Care - Los Angeles- Rock Central Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Piedmont Eye Center - Lynchburg Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| AMA Eye Research Institute Coordinator of this site? Confirm its status | Marysville | United States | Unknown status |
| Total Eye Care, P.A. Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| North Valley Eye Medical Group, Inc. Coordinator of this site? Confirm its status | Mission Hills | United States | Unknown status |
| California Eye Specialists Medical Group Inc. - Monrovia Coordinator of this site? Confirm its status | Monrovia | United States | Unknown status |
| Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Aesthetic Eye Care Institute - Eye Research Foundation Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Ocala Eye - 3130 Location Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Bascom Palmer Eye Institute - University of Miami Health System - Palm Beach Gardens Coordinator of this site? Confirm its status | Palm Beach Gardens | United States | Unknown status |
| Foothill Eye Institute - Pasadena Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| North Bay Eye Associates - Petaluma - 104 Lynch Creek Way Coordinator of this site? Confirm its status | Petaluma | United States | Unknown status |
| Scheie Eye Institute - University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Wills Eye Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Arizona Glaucoma Specialists - Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Legacy Pulmonary Medical Group - Good Samaritan Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| California Eye Specialists Medical Group Inc. - Redlands Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Rochester Ophthalmological Group, PC - Brighton Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Coastal Research Associates, LLC. - Atlanta Coordinator of this site? Confirm its status | Roswell | United States | Unknown status |
| Great Lakes Eye Care - St. Joseph Coordinator of this site? Confirm its status | Saint Joseph | United States | Unknown status |
| Rashid, Rice, Flynn & Reilly Eye Associates - San Antonio Clinic Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| San Antonio Eye Center, P.A. - McCullough Ave Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| OC Surgical Eye Institute Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Santa Barbara Eyecare - Santa Barbara Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| St. George Eye Center - St. George Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| East Florida Eye Institute Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
| Walman Eye Center - Sun City Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| Wolstan & Goldberg Eye Associates Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Comprehensive Eye Care, Ltd. Coordinator of this site? Confirm its status | Washington | United States | Unknown status |
| "Clinic-LJ" Ltd Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Huron Ophthalmology, P.C. Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.