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

Last updated: July 17, 2024
Sponsor: Laboratoires Thea
Overall Status: Completed

Phase

3

Condition

Glaucoma

Ocular Hypertension

Treatment

Bimatoprost Ophthalmic

Clinical Study ID

NCT05397600
LT4032-302
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Informed consent dated and signed.

  • Both eyes diagnosed open-angle glaucoma or ocular hypertension

Exclusion

Exclusion Criteria:

  • History of trauma, infection, clinically significant inflammation within theprevious 3 months

  • Known or suspected hypersensitivity to one of the components of the InvestigationalMedicinal Product(s)

  • Pregnancy or breast-feeding

Study Design

Total Participants: 684
Treatment Group(s): 1
Primary Treatment: Bimatoprost Ophthalmic
Phase: 3
Study Start date:
June 22, 2022
Estimated Completion Date:
March 07, 2024

Connect with a study center

  • Prism Eye Institute - Oakville

    Oakville, Ontario L6H 0J8
    Canada

    Site Not Available

  • Clinique Bellevue - Laval

    Laval, Quebec H7N 4B2
    Canada

    Site Not Available

  • Clínica Oftalmológica del Caribe

    Barranquilla, 80001
    Colombia

    Site Not Available

  • Fundación Oftalmológica Nacional (FUNDONAL)

    Bogotá, 110231
    Colombia

    Site Not Available

  • Clinica de Oftalmologia de Cali SA

    Cali, 760001
    Colombia

    Site Not Available

  • Fundación Oftalmológica de Santander FOSCAL

    Floridablanca, 681004
    Colombia

    Site Not Available

  • Instituto Nacional de Investigacion en Oftalmologia

    Medellin, 050021
    Colombia

    Site Not Available

  • Clinica de Oftalmologia Sandiego

    Medellín, 050016
    Colombia

    Site Not Available

  • Arizona Eye Center - Chandler

    Chandler, Arizona 85224-0002
    United States

    Site Not Available

  • Eye Physicians & Surgeons of Arizona - Glendale Office

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Glaucoma Specialists - Phoenix

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • Walman Eye Center - Sun City

    Sun City, Arizona 85351-3019
    United States

    Site Not Available

  • Velvet Clinical Research

    Burbank, California 91506-1773
    United States

    Site Not Available

  • Global Research Management, Inc.

    Glendale, California 91204-2500
    United States

    Site Not Available

  • Specialty Eye Care Medical Center - Glendale

    Glendale, California 91203-2001
    United States

    Site Not Available

  • Inland Eye Specialists - Hemet

    Hemet, California 92545-9687
    United States

    Site Not Available

  • Diabetic Eye Medical Clinic - Inglewood

    Inglewood, California 90301-1413
    United States

    Site Not Available

  • Lakeside Vision Center - Irvine

    Irvine, California 92604-1726
    United States

    Site Not Available

  • Global Vision Eye Care - Los Angeles- Rock Central

    Los Angeles, California 90041-1718
    United States

    Site Not Available

  • Sage Eyecare

    Los Angeles, California 90017
    United States

    Site Not Available

  • North Valley Eye Medical Group, Inc.

    Mission Hills, California 91345-1246
    United States

    Site Not Available

  • California Eye Specialists Medical Group Inc. - Monrovia

    Monrovia, California 91016-1938
    United States

    Site Not Available

  • Aesthetic Eye Care Institute - Eye Research Foundation

    Newport Beach, California 92663-3642
    United States

    Site Not Available

  • Foothill Eye Institute - Pasadena

    Pasadena, California 91107-3747
    United States

    Site Not Available

  • North Bay Eye Associates - Petaluma - 104 Lynch Creek Way

    Petaluma, California 94954-2355
    United States

    Site Not Available

  • California Eye Specialists Medical Group Inc. - Redlands

    Redlands, California 92373-3125
    United States

    Site Not Available

  • OC Surgical Eye Institute

    Santa Ana, California 92705-4079
    United States

    Site Not Available

  • Santa Barbara Eyecare - Santa Barbara

    Santa Barbara, California 93105-3310
    United States

    Site Not Available

  • Wolstan & Goldberg Eye Associates

    Torrance, California 90505-4036
    United States

    Site Not Available

  • ICON Eye Care - Grand Junction

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Nature Coast Clinical Research - Crystal River

    Crystal River, Florida 34429-8722
    United States

    Site Not Available

  • East Coast Institute for Research - Jacksonville

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Ocala Eye - 3130 Location

    Ocala, Florida 34474-4445
    United States

    Site Not Available

  • Bascom Palmer Eye Institute - University of Miami Health System - Palm Beach Gardens

    Palm Beach Gardens, Florida 33418-3701
    United States

    Site Not Available

  • East Florida Eye Institute

    Stuart, Florida 34994-2579
    United States

    Site Not Available

  • Coastal Research Associates, LLC. - Atlanta

    Roswell, Georgia 30076-5610
    United States

    Site Not Available

  • Indiana University School of Medicine - Eugene and Marilyn Glick Eye Institute

    Indianapolis, Indiana 46202-5209
    United States

    Site Not Available

  • Fraser Eye Care Center - Fraser

    Fraser, Michigan 48026-2038
    United States

    Site Not Available

  • Great Lakes Eye Care - St. Joseph

    Saint Joseph, Michigan 49085-3352
    United States

    Site Not Available

  • Huron Ophthalmology, P.C.

    Ypsilanti, Michigan 48197-1102
    United States

    Site Not Available

  • Comprehensive Eye Care, Ltd.

    Washington, Missouri 63090-3010
    United States

    Site Not Available

  • NV Eye Surgery - Henderson

    Henderson, Nevada 89052-5084
    United States

    Site Not Available

  • Rochester Ophthalmological Group, PC - Brighton

    Rochester, New York 14618-2616
    United States

    Site Not Available

  • "Clinic-LJ" Ltd

    Winston-Salem, North Carolina 27101-3911
    United States

    Site Not Available

  • Cincinnati Eye Institute - Blue Ash

    Cincinnati, Ohio 45242-5664
    United States

    Site Not Available

  • Abrams Eye Center, Inc.

    Cleveland, Ohio 44115-3100
    United States

    Site Not Available

  • AMA Eye Research Institute

    Marysville, Ohio 43040
    United States

    Site Not Available

  • Legacy Pulmonary Medical Group - Good Samaritan Medical Center

    Portland, Oregon 97210-3049
    United States

    Site Not Available

  • Scott & White Cancer Center - Killeen

    Cranberry Township, Pennsylvania 16066-6412
    United States

    Site Not Available

  • Scheie Eye Institute

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Scheie Eye Institute - University of Pennsylvania

    Philadelphia, Pennsylvania 19104-2640
    United States

    Site Not Available

  • Wills Eye Hospital

    Philadelphia, Pennsylvania 19107-5109
    United States

    Site Not Available

  • Advancing Vision Research - Goodlettsville

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Total Eye Care, P.A.

    Memphis, Tennessee 38119-5770
    United States

    Site Not Available

  • Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus

    Nashville, Tennessee 37232-0025
    United States

    Site Not Available

  • Texan Eye - Austin - Main Central

    Austin, Texas 78731-4203
    United States

    Site Not Available

  • Southwest Eye Institute

    El Paso, Texas 79902
    United States

    Site Not Available

  • Houston Eye Associates (HEA) - Gramercy Location

    Houston, Texas 77025-1756
    United States

    Site Not Available

  • Houston Eye Associates - North Loop

    Houston, Texas 77022-5332
    United States

    Site Not Available

  • Rashid, Rice, Flynn & Reilly Eye Associates - San Antonio Clinic

    San Antonio, Texas 78229-3539
    United States

    Site Not Available

  • San Antonio Eye Center, P.A. - McCullough Ave

    San Antonio, Texas 78215-1625
    United States

    Site Not Available

  • St. George Eye Center - St. George

    Saint George, Utah 84790-8720
    United States

    Site Not Available

  • Piedmont Eye Center - Lynchburg

    Lynchburg, Virginia 24502-4271
    United States

    Site Not Available

  • Specialty Eye Care Center - Bellevue

    Bellevue, Washington 98004-3019
    United States

    Site Not Available

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