Clinical trial NCT05397600: Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Official title: Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.


Eligibility criteria: Inclusion Criteria:

* Informed consent dated and signed.
* Both eyes diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
timeFrame: up to Week12
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center - Chandler
state: Arizona
city: Glendale
country: United States
facility: Eye Physicians & Surgeons of Arizona - Glendale Office
state: Arizona
city: Phoenix
country: United States
facility: Arizona Glaucoma Specialists - Phoenix
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center - Sun City
state: Arizona
city: Burbank
country: United States
facility: Velvet Clinical Research
state: California
city: Glendale
country: United States
facility: Specialty Eye Care Medical Center - Glendale
state: California
city: Glendale
country: United States
facility: Global Research Management, Inc.
state: California
city: Hemet
country: United States
facility: Inland Eye Specialists - Hemet
state: California
city: Inglewood
country: United States
facility: Diabetic Eye Medical Clinic - Inglewood
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center - Irvine
state: California
city: Los Angeles
country: United States
facility: Sage Eyecare
state: California
city: Los Angeles
country: United States
facility: Global Vision Eye Care - Los Angeles- Rock Central
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc.
state: California
city: Monrovia
country: United States
facility: California Eye Specialists Medical Group Inc. - Monrovia
state: California
city: Newport Beach
country: United States
facility: Aesthetic Eye Care Institute - Eye Research Foundation
state: California
city: Pasadena
country: United States
facility: Foothill Eye Institute - Pasadena
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates - Petaluma - 104 Lynch Creek Way
state: California
city: Redlands
country: United States
facility: California Eye Specialists Medical Group Inc. - Redlands
state: California
city: Santa Ana
country: United States
facility: OC Surgical Eye Institute
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Eyecare - Santa Barbara
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Grand Junction
country: United States
facility: ICON Eye Care - Grand Junction
state: Colorado
city: Crystal River
country: United States
facility: Nature Coast Clinical Research - Crystal River
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research - Jacksonville
state: Florida
city: Ocala
country: United States
facility: Ocala Eye - 3130 Location
state: Florida
city: Palm Beach Gardens
country: United States
facility: Bascom Palmer Eye Institute - University of Miami Health System - Palm Beach Gardens
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates, LLC. - Atlanta
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates, LLC. - Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine - Eugene and Marilyn Glick Eye Institute
state: Indiana
city: Fraser
country: United States
facility: Fraser Eye Care Center - Fraser
state: Michigan
city: Saint Joseph
country: United States
facility: Great Lakes Eye Care - St. Joseph
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Ophthalmology, P.C.
state: Michigan
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Henderson
country: United States
facility: NV Eye Surgery - Henderson
state: Nevada
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC - Brighton
state: New York
city: Winston-Salem
country: United States
facility: "Clinic-LJ" Ltd
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute - Blue Ash
state: Ohio
city: Cleveland
country: United States
facility: Abrams Eye Center, Inc.
state: Ohio
city: Marysville
country: United States
facility: AMA Eye Research Institute
state: Ohio
city: Portland
country: United States
facility: Legacy Pulmonary Medical Group - Good Samaritan Medical Center
state: Oregon
city: Cranberry Township
country: United States
facility: Scott & White Cancer Center - Killeen
state: Pennsylvania
city: Philadelphia
country: United States
facility: Scheie Eye Institute - University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Advancing Vision Research - Goodlettsville
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus
state: Tennessee
city: Austin
country: United States
facility: Texan Eye - Austin - Main Central
state: Texas
city: El Paso
country: United States
facility: Southwest Eye Institute
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates - North Loop
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates (HEA) - Gramercy Location
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center, P.A. - McCullough Ave
state: Texas
city: San Antonio
country: United States
facility: Rashid, Rice, Flynn & Reilly Eye Associates - San Antonio Clinic
state: Texas
city: Saint George
country: United States
facility: St. George Eye Center - St. George
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center - Lynchburg
state: Virginia
city: Bellevue
country: United States
facility: Specialty Eye Care Center - Bellevue
state: Washington
city: Oakville
country: Canada
facility: Prism Eye Institute - Oakville
state: Ontario
city: Laval
country: Canada
facility: Clinique Bellevue - Laval
state: Quebec
city: Barranquilla
country: Colombia
facility: Clínica Oftalmológica del Caribe
city: Bogotá
country: Colombia
facility: Fundación Oftalmológica Nacional (FUNDONAL)
city: Cali
country: Colombia
facility: Clinica de Oftalmologia de Cali SA
city: Floridablanca
country: Colombia
facility: Fundación Oftalmológica de Santander FOSCAL
city: Medellin
country: Colombia
facility: Instituto Nacional de Investigacion en Oftalmologia
city: Medellín
country: Colombia
facility: Clinica de Oftalmologia Sandiego
Study officials:
References: