Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients

July 17, 2024 updated by: Laboratoires Thea
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

684

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6H 0J8
        • Prism Eye Institute - Oakville
    • Quebec
      • Laval, Quebec, Canada, H7N 4B2
        • Clinique Bellevue - Laval
  • Colombia
      • Barranquilla, Colombia, 80001
        • Clinica Oftalmologica del Caribe
      • Bogotá, Colombia, 110231
        • Fundación Oftalmológica Nacional (FUNDONAL)
      • Cali, Colombia, 760001
        • Clinica de Oftalmologia de Cali SA
      • Floridablanca, Colombia, 681004
        • Fundacion Oftalmologica de Santander FOSCAL
      • Medellin, Colombia, 050021
        • Instituto Nacional de Investigacion en Oftalmologia
      • Medellín, Colombia, 050016
        • Clinica de Oftalmologia Sandiego
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224-0002
        • Arizona Eye Center - Chandler
      • Glendale, Arizona, United States, 85306
        • Eye Physicians & Surgeons of Arizona - Glendale Office
      • Phoenix, Arizona, United States, 85050
        • Arizona Glaucoma Specialists - Phoenix
      • Sun City, Arizona, United States, 85351-3019
        • Walman Eye Center - Sun City
    • California
      • Burbank, California, United States, 91506-1773
        • Velvet Clinical Research
      • Glendale, California, United States, 91203-2001
        • Specialty Eye Care Medical Center - Glendale
      • Glendale, California, United States, 91204-2500
        • Global Research Management, Inc.
      • Hemet, California, United States, 92545-9687
        • Inland Eye Specialists - Hemet
      • Inglewood, California, United States, 90301-1413
        • Diabetic Eye Medical Clinic - Inglewood
      • Irvine, California, United States, 92604-1726
        • Lakeside Vision Center - Irvine
      • Los Angeles, California, United States, 90017
        • Sage Eyecare
      • Los Angeles, California, United States, 90041-1718
        • Global Vision Eye Care - Los Angeles- Rock Central
      • Mission Hills, California, United States, 91345-1246
        • North Valley Eye Medical Group, Inc.
      • Monrovia, California, United States, 91016-1938
        • California Eye Specialists Medical Group Inc. - Monrovia
      • Newport Beach, California, United States, 92663-3642
        • Aesthetic Eye Care Institute - Eye Research Foundation
      • Pasadena, California, United States, 91107-3747
        • Foothill Eye Institute - Pasadena
      • Petaluma, California, United States, 94954-2355
        • North Bay Eye Associates - Petaluma - 104 Lynch Creek Way
      • Redlands, California, United States, 92373-3125
        • California Eye Specialists Medical Group Inc. - Redlands
      • Santa Ana, California, United States, 92705-4079
        • OC Surgical Eye Institute
      • Santa Barbara, California, United States, 93105-3310
        • Santa Barbara Eyecare - Santa Barbara
      • Torrance, California, United States, 90505-4036
        • Wolstan & Goldberg Eye Associates
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • ICON Eye Care - Grand Junction
    • Florida
      • Crystal River, Florida, United States, 34429-8722
        • Nature Coast Clinical Research - Crystal River
      • Jacksonville, Florida, United States, 32256
        • East Coast Institute for Research - Jacksonville
      • Ocala, Florida, United States, 34474-4445
        • Ocala Eye - 3130 Location
      • Palm Beach Gardens, Florida, United States, 33418-3701
        • Bascom Palmer Eye Institute - University of Miami Health System - Palm Beach Gardens
      • Stuart, Florida, United States, 34994-2579
        • East Florida Eye Institute
    • Georgia
      • Roswell, Georgia, United States, 30076-5610
        • Coastal Research Associates, LLC. - Atlanta
      • Roswell, Georgia, United States, 30076-5650
        • Coastal Research Associates, LLC. - Atlanta
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5209
        • Indiana University School of Medicine - Eugene and Marilyn Glick Eye Institute
    • Michigan
      • Fraser, Michigan, United States, 48026-2038
        • Fraser Eye Care Center - Fraser
      • Saint Joseph, Michigan, United States, 49085-3352
        • Great Lakes Eye Care - St. Joseph
      • Ypsilanti, Michigan, United States, 48197-1102
        • Huron Ophthalmology, P.C.
    • Missouri
      • Washington, Missouri, United States, 63090-3010
        • Comprehensive Eye Care, Ltd.
    • Nevada
      • Henderson, Nevada, United States, 89052-5084
        • NV Eye Surgery - Henderson
    • New York
      • Rochester, New York, United States, 14618-2616
        • Rochester Ophthalmological Group, PC - Brighton
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27101-3911
        • "Clinic-LJ" Ltd
    • Ohio
      • Cincinnati, Ohio, United States, 45242-5664
        • Cincinnati Eye Institute - Blue Ash
      • Cleveland, Ohio, United States, 44115-3100
        • Abrams Eye Center, Inc.
      • Marysville, Ohio, United States, 43040
        • AMA Eye Research Institute
    • Oregon
      • Portland, Oregon, United States, 97210-3049
        • Legacy Pulmonary Medical Group - Good Samaritan Medical Center
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066-6412
        • Scott & White Cancer Center - Killeen
      • Philadelphia, Pennsylvania, United States, 19104-2640
        • Scheie Eye Institute - University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5109
        • Wills Eye Hospital
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Advancing Vision Research - Goodlettsville
      • Memphis, Tennessee, United States, 38119-5770
        • Total Eye Care, P.A.
      • Nashville, Tennessee, United States, 37232-0025
        • Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus
    • Texas
      • Austin, Texas, United States, 78731-4203
        • Texan Eye - Austin - Main Central
      • El Paso, Texas, United States, 79902
        • Southwest Eye Institute
      • Houston, Texas, United States, 77022-5332
        • Houston Eye Associates - North Loop
      • Houston, Texas, United States, 77025-1756
        • Houston Eye Associates (HEA) - Gramercy Location
      • San Antonio, Texas, United States, 78215-1625
        • San Antonio Eye Center, P.A. - McCullough Ave
      • San Antonio, Texas, United States, 78229-3539
        • Rashid, Rice, Flynn & Reilly Eye Associates - San Antonio Clinic
    • Utah
      • Saint George, Utah, United States, 84790-8720
        • St. George Eye Center - St. George
    • Virginia
      • Lynchburg, Virginia, United States, 24502-4271
        • Piedmont Eye Center - Lynchburg
    • Washington
      • Bellevue, Washington, United States, 98004-3019
        • Specialty Eye Care Center - Bellevue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T4032
Drug: Bimatoprost Ophthalmic
Eyedrops
Active Comparator: Lumigan
Drug: Bimatoprost Ophthalmic
Eyedrops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
Time Frame: 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.
up to Week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Actual)

March 7, 2024

Study Completion (Actual)

March 7, 2024

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT4032-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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