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

NCT ID: NCT05397600

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

684 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-22

Study Completion Date

2024-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

T4032

Group Type EXPERIMENTAL

Bimatoprost Ophthalmic

Intervention Type DRUG

Eyedrops

Lumigan

Group Type ACTIVE_COMPARATOR

Bimatoprost Ophthalmic

Intervention Type DRUG

Eyedrops

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bimatoprost Ophthalmic

Eyedrops

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Eye Center - Chandler

Chandler, Arizona, United States

Site Status

Eye Physicians & Surgeons of Arizona - Glendale Office

Glendale, Arizona, United States

Site Status

Arizona Glaucoma Specialists - Phoenix

Phoenix, Arizona, United States

Site Status

Walman Eye Center - Sun City

Sun City, Arizona, United States

Site Status

Velvet Clinical Research

Burbank, California, United States

Site Status

Specialty Eye Care Medical Center - Glendale

Glendale, California, United States

Site Status

Global Research Management, Inc.

Glendale, California, United States

Site Status

Inland Eye Specialists - Hemet

Hemet, California, United States

Site Status

Diabetic Eye Medical Clinic - Inglewood

Inglewood, California, United States

Site Status

Lakeside Vision Center - Irvine

Irvine, California, United States

Site Status

Sage Eyecare

Los Angeles, California, United States

Site Status

Global Vision Eye Care - Los Angeles- Rock Central

Los Angeles, California, United States

Site Status

North Valley Eye Medical Group, Inc.

Mission Hills, California, United States

Site Status

California Eye Specialists Medical Group Inc. - Monrovia

Monrovia, California, United States

Site Status

Aesthetic Eye Care Institute - Eye Research Foundation

Newport Beach, California, United States

Site Status

Foothill Eye Institute - Pasadena

Pasadena, California, United States

Site Status

North Bay Eye Associates - Petaluma - 104 Lynch Creek Way

Petaluma, California, United States

Site Status

California Eye Specialists Medical Group Inc. - Redlands

Redlands, California, United States

Site Status

OC Surgical Eye Institute

Santa Ana, California, United States

Site Status

Santa Barbara Eyecare - Santa Barbara

Santa Barbara, California, United States

Site Status

Wolstan & Goldberg Eye Associates

Torrance, California, United States

Site Status

ICON Eye Care - Grand Junction

Grand Junction, Colorado, United States

Site Status

Nature Coast Clinical Research - Crystal River

Crystal River, Florida, United States

Site Status

East Coast Institute for Research - Jacksonville

Jacksonville, Florida, United States

Site Status

Ocala Eye - 3130 Location

Ocala, Florida, United States

Site Status

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

Palm Beach Gardens, Florida, United States

Site Status

East Florida Eye Institute

Stuart, Florida, United States

Site Status

Coastal Research Associates, LLC. - Atlanta

Roswell, Georgia, United States

Site Status

Coastal Research Associates, LLC. - Atlanta

Roswell, Georgia, United States

Site Status

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

Indianapolis, Indiana, United States

Site Status

Fraser Eye Care Center - Fraser

Fraser, Michigan, United States

Site Status

Great Lakes Eye Care - St. Joseph

Saint Joseph, Michigan, United States

Site Status

Huron Ophthalmology, P.C.

Ypsilanti, Michigan, United States

Site Status

Comprehensive Eye Care, Ltd.

Washington, Missouri, United States

Site Status

NV Eye Surgery - Henderson

Henderson, Nevada, United States

Site Status

Rochester Ophthalmological Group, PC - Brighton

Rochester, New York, United States

Site Status

"Clinic-LJ" Ltd

Winston-Salem, North Carolina, United States

Site Status

Cincinnati Eye Institute - Blue Ash

Cincinnati, Ohio, United States

Site Status

Abrams Eye Center, Inc.

Cleveland, Ohio, United States

Site Status

AMA Eye Research Institute

Marysville, Ohio, United States

Site Status

Legacy Pulmonary Medical Group - Good Samaritan Medical Center

Portland, Oregon, United States

Site Status

Scott & White Cancer Center - Killeen

Cranberry Township, Pennsylvania, United States

Site Status

Scheie Eye Institute - University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Advancing Vision Research - Goodlettsville

Goodlettsville, Tennessee, United States

Site Status

Total Eye Care, P.A.

Memphis, Tennessee, United States

Site Status

Vanderbilt University Medical Center - Vanderbilt Eye Institute - Main Campus

Nashville, Tennessee, United States

Site Status

Texan Eye - Austin - Main Central

Austin, Texas, United States

Site Status

Southwest Eye Institute

El Paso, Texas, United States

Site Status

Houston Eye Associates - North Loop

Houston, Texas, United States

Site Status

Houston Eye Associates (HEA) - Gramercy Location

Houston, Texas, United States

Site Status

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

San Antonio, Texas, United States

Site Status

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

San Antonio, Texas, United States

Site Status

St. George Eye Center - St. George

St. George, Utah, United States

Site Status

Piedmont Eye Center - Lynchburg

Lynchburg, Virginia, United States

Site Status

Specialty Eye Care Center - Bellevue

Bellevue, Washington, United States

Site Status

Prism Eye Institute - Oakville

Oakville, Ontario, Canada

Site Status

Clinique Bellevue - Laval

Laval, Quebec, Canada

Site Status

Clínica Oftalmológica del Caribe

Barranquilla, , Colombia

Site Status

Fundación Oftalmológica Nacional (FUNDONAL)

Bogotá, , Colombia

Site Status

Clinica de Oftalmologia de Cali SA

Cali, , Colombia

Site Status

Fundación Oftalmológica de Santander FOSCAL

Floridablanca, , Colombia

Site Status

Clinica de Oftalmologia Sandiego

Medellín, , Colombia

Site Status

Instituto Nacional de Investigacion en Oftalmologia

Medellín, , Colombia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Colombia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LT4032-302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lumigan Versus Cosopt
NCT00273455 COMPLETED PHASE4