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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
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

Full criteria on ClinicalTrials.gov

Sites (63)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinique Bellevue - Laval
Coordinator of this site? Confirm its status
LavalCanadaUnknown status
Prism Eye Institute - Oakville
Coordinator of this site? Confirm its status
OakvilleCanadaUnknown status
Clinica Oftalmologica del Caribe
Coordinator of this site? Confirm its status
BarranquillaColombiaUnknown status
Fundación Oftalmológica Nacional (FUNDONAL)
Coordinator of this site? Confirm its status
BogotáColombiaUnknown status
Clinica de Oftalmologia de Cali SA
Coordinator of this site? Confirm its status
CaliColombiaUnknown status
Fundacion Oftalmologica de Santander - FOSCAL
Coordinator of this site? Confirm its status
FloridablancaColombiaUnknown status
Clinica de Oftalmologia Sandiego
Coordinator of this site? Confirm its status
MedellínColombiaUnknown status
Instituto Nacional de Investigacion en Oftalmologia
Coordinator of this site? Confirm its status
MedellínColombiaUnknown status
Texan Eye - Austin - Main Central
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Specialty Eye Care Center - Bellevue
Coordinator of this site? Confirm its status
BellevueUnited StatesUnknown status
Velvet Clinical Research
Coordinator of this site? Confirm its status
BurbankUnited StatesUnknown status
Arizona Eye Center - Chandler
Coordinator of this site? Confirm its status
ChandlerUnited StatesUnknown status
Cincinnati Eye Institute - Blue Ash
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Abrams Eye Center, Inc.
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Scott & White Cancer Center - Killeen
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Cranberry TownshipUnited StatesUnknown status
Nature Coast Clinical Research - Crystal River
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Crystal RiverUnited StatesUnknown status
Southwest Eye Institute
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El PasoUnited StatesUnknown status
Fraser Eye Care Center - Fraser
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FraserUnited StatesUnknown status
Specialty Eye Care Medical Center - Glendale
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GlendaleUnited StatesUnknown status
Global Research Management, Inc
Coordinator of this site? Confirm its status
GlendaleUnited StatesUnknown status
Eye Physicians & Surgeons of Arizona - Glendale Office
Coordinator of this site? Confirm its status
GlendaleUnited StatesUnknown status
Advancing Vision Research - Goodlettsville
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GoodlettsvilleUnited StatesUnknown status
ICON Eye Care - Grand Junction
Coordinator of this site? Confirm its status
Grand JunctionUnited StatesUnknown status
Inland Eye Specialists - Hemet
Coordinator of this site? Confirm its status
HemetUnited StatesUnknown status
NV Eye Surgery - Henderson
Coordinator of this site? Confirm its status
HendersonUnited StatesUnknown status
Houston Eye Associates (HEA) - Gramercy Location
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Houston Eye Associates, North Loop
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Indiana University School of Medicine - Eugene and Marilyn Glick Eye Institute
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Diabetic Eye Medical Clinic - Inglewood
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InglewoodUnited StatesUnknown status
Lakeside Vision Center - Irvine
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IrvineUnited StatesUnknown status
East Coast Institute for Research, Jacksonville
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JacksonvilleUnited StatesUnknown status
Sage Eyecare
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Los AngelesUnited StatesUnknown status
Global Vision Eye Care - Los Angeles- Rock Central
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Los AngelesUnited StatesUnknown status
Piedmont Eye Center - Lynchburg
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LynchburgUnited StatesUnknown status
AMA Eye Research Institute
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MarysvilleUnited StatesUnknown status
Total Eye Care, P.A.
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
North Valley Eye Medical Group, Inc.
Coordinator of this site? Confirm its status
Mission HillsUnited StatesUnknown status
California Eye Specialists Medical Group Inc. - Monrovia
Coordinator of this site? Confirm its status
MonroviaUnited StatesUnknown status
Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Aesthetic Eye Care Institute - Eye Research Foundation
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Newport BeachUnited StatesUnknown status
Ocala Eye - 3130 Location
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OcalaUnited StatesUnknown status
Bascom Palmer Eye Institute - University of Miami Health System - Palm Beach Gardens
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Palm Beach GardensUnited StatesUnknown status
Foothill Eye Institute - Pasadena
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PasadenaUnited StatesUnknown status
North Bay Eye Associates - Petaluma - 104 Lynch Creek Way
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PetalumaUnited StatesUnknown status
Scheie Eye Institute - University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Wills Eye Hospital
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PhiladelphiaUnited StatesUnknown status
Arizona Glaucoma Specialists - Phoenix
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PhoenixUnited StatesUnknown status
Legacy Pulmonary Medical Group - Good Samaritan Medical Center
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
California Eye Specialists Medical Group Inc. - Redlands
Coordinator of this site? Confirm its status
RedlandsUnited StatesUnknown status
Rochester Ophthalmological Group, PC - Brighton
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RochesterUnited StatesUnknown status
Coastal Research Associates, LLC. - Atlanta
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RoswellUnited StatesUnknown status
Great Lakes Eye Care - St. Joseph
Coordinator of this site? Confirm its status
Saint JosephUnited StatesUnknown status
Rashid, Rice, Flynn & Reilly Eye Associates - San Antonio Clinic
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
San Antonio Eye Center, P.A. - McCullough Ave
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San AntonioUnited StatesUnknown status
OC Surgical Eye Institute
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Santa AnaUnited StatesUnknown status
Santa Barbara Eyecare - Santa Barbara
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Santa BarbaraUnited StatesUnknown status
St. George Eye Center - St. George
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St. GeorgeUnited StatesUnknown status
East Florida Eye Institute
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StuartUnited StatesUnknown status
Walman Eye Center - Sun City
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Sun CityUnited StatesUnknown status
Wolstan & Goldberg Eye Associates
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TorranceUnited StatesUnknown status
Comprehensive Eye Care, Ltd.
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WashingtonUnited StatesUnknown status
"Clinic-LJ" Ltd
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Winston-SalemUnited StatesUnknown status
Huron Ophthalmology, P.C.
Coordinator of this site? Confirm its status
YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.