Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
1 other identifier
interventional
684
3 countries
64
Brief Summary
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2022
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
June 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2024
CompletedJuly 18, 2024
November 1, 2023
1.7 years
May 25, 2022
July 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
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.
up to Week12
Study Arms (2)
T4032
EXPERIMENTALLumigan
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Informed consent dated and signed.
- Both eyes diagnosed open-angle glaucoma or ocular hypertension
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Arizona Eye Center - Chandler
Chandler, Arizona, 85224-0002, United States
Eye Physicians & Surgeons of Arizona - Glendale Office
Glendale, Arizona, 85306, United States
Arizona Glaucoma Specialists - Phoenix
Phoenix, Arizona, 85050, United States
Walman Eye Center - Sun City
Sun City, Arizona, 85351-3019, United States
Velvet Clinical Research
Burbank, California, 91506-1773, United States
Specialty Eye Care Medical Center - Glendale
Glendale, California, 91203-2001, United States
Global Research Management, Inc.
Glendale, California, 91204-2500, United States
Inland Eye Specialists - Hemet
Hemet, California, 92545-9687, United States
Diabetic Eye Medical Clinic - Inglewood
Inglewood, California, 90301-1413, United States
Lakeside Vision Center - Irvine
Irvine, California, 92604-1726, United States
Sage Eyecare
Los Angeles, California, 90017, United States
Global Vision Eye Care - Los Angeles- Rock Central
Los Angeles, California, 90041-1718, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, 91345-1246, United States
California Eye Specialists Medical Group Inc. - Monrovia
Monrovia, California, 91016-1938, United States
Aesthetic Eye Care Institute - Eye Research Foundation
Newport Beach, California, 92663-3642, United States
Foothill Eye Institute - Pasadena
Pasadena, California, 91107-3747, United States
North Bay Eye Associates - Petaluma - 104 Lynch Creek Way
Petaluma, California, 94954-2355, United States
California Eye Specialists Medical Group Inc. - Redlands
Redlands, California, 92373-3125, United States
OC Surgical Eye Institute
Santa Ana, California, 92705-4079, United States
Santa Barbara Eyecare - Santa Barbara
Santa Barbara, California, 93105-3310, United States
Wolstan & Goldberg Eye Associates
Torrance, California, 90505-4036, United States
ICON Eye Care - Grand Junction
Grand Junction, Colorado, 81501, United States
Nature Coast Clinical Research - Crystal River
Crystal River, Florida, 34429-8722, United States
East Coast Institute for Research - Jacksonville
Jacksonville, Florida, 32256, United States
Ocala Eye - 3130 Location
Ocala, Florida, 34474-4445, United States
Bascom Palmer Eye Institute - University of Miami Health System - Palm Beach Gardens
Palm Beach Gardens, Florida, 33418-3701, United States
East Florida Eye Institute
Stuart, Florida, 34994-2579, United States
Coastal Research Associates, LLC. - Atlanta
Roswell, Georgia, 30076-5610, United States
Coastal Research Associates, LLC. - Atlanta
Roswell, Georgia, 30076-5650, United States
Indiana University School of Medicine - Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, 46202-5209, United States
Fraser Eye Care Center - Fraser
Fraser, Michigan, 48026-2038, United States
Great Lakes Eye Care - St. Joseph
Saint Joseph, Michigan, 49085-3352, United States
Huron Ophthalmology, P.C.
Ypsilanti, Michigan, 48197-1102, United States
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090-3010, United States
NV Eye Surgery - Henderson
Henderson, Nevada, 89052-5084, United States
Rochester Ophthalmological Group, PC - Brighton
Rochester, New York, 14618-2616, United States
"Clinic-LJ" Ltd
Winston-Salem, North Carolina, 27101-3911, United States
Cincinnati Eye Institute - Blue Ash
Cincinnati, Ohio, 45242-5664, United States
Abrams Eye Center, Inc.
Cleveland, Ohio, 44115-3100, United States
AMA Eye Research Institute
Marysville, Ohio, 43040, United States
Legacy Pulmonary Medical Group - Good Samaritan Medical Center
Portland, Oregon, 97210-3049, United States
Scott & White Cancer Center - Killeen
Cranberry Township, Pennsylvania, 16066-6412, United States
Scheie Eye Institute - University of Pennsylvania
Philadelphia, Pennsylvania, 19104-2640, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107-5109, United States
Advancing Vision Research - Goodlettsville
Goodlettsville, Tennessee, 37072, United States
Total Eye Care, P.A.
Memphis, Tennessee, 38119-5770, United States
Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus
Nashville, Tennessee, 37232-0025, United States
Texan Eye - Austin - Main Central
Austin, Texas, 78731-4203, United States
Southwest Eye Institute
El Paso, Texas, 79902, United States
Houston Eye Associates - North Loop
Houston, Texas, 77022-5332, United States
Houston Eye Associates (HEA) - Gramercy Location
Houston, Texas, 77025-1756, United States
San Antonio Eye Center, P.A. - McCullough Ave
San Antonio, Texas, 78215-1625, United States
Rashid, Rice, Flynn & Reilly Eye Associates - San Antonio Clinic
San Antonio, Texas, 78229-3539, United States
St. George Eye Center - St. George
St. George, Utah, 84790-8720, United States
Piedmont Eye Center - Lynchburg
Lynchburg, Virginia, 24502-4271, United States
Specialty Eye Care Center - Bellevue
Bellevue, Washington, 98004-3019, United States
Prism Eye Institute - Oakville
Oakville, Ontario, L6H 0J8, Canada
Clinique Bellevue - Laval
Laval, Quebec, H7N 4B2, Canada
Clínica Oftalmológica del Caribe
Barranquilla, 80001, Colombia
Fundación Oftalmológica Nacional (FUNDONAL)
Bogotá, 110231, Colombia
Clinica de Oftalmologia de Cali SA
Cali, 760001, Colombia
Fundación Oftalmológica de Santander FOSCAL
Floridablanca, 681004, Colombia
Clinica de Oftalmologia Sandiego
Medellín, 050016, Colombia
Instituto Nacional de Investigacion en Oftalmologia
Medellín, 050021, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
June 22, 2022
Primary Completion
March 7, 2024
Study Completion
March 7, 2024
Last Updated
July 18, 2024
Record last verified: 2023-11