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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
684

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: T4032
Drug: Bimatoprost Ophthalmic
Eyedrops
Active Comparator: Lumigan
Drug: Bimatoprost Ophthalmic
Eyedrops

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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