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

March 19, 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

  • Colombia
      • Barranquilla, Colombia, 80001
        • Clínica Oftalmológica del Caribe
      • Bogotá, Colombia, 110231
        • Fundación Oftalmológica Nacional (FUNDONAL)
      • Cali, Colombia, 760001
        • Clinica de Oftalmologia de Cali SA
      • Floridablanca, Colombia, 681004
        • Fundación Oftalmológica de Santander FOSCAL
      • Medellin, Colombia, 50024
        • Instituto Nacional de Investigacion en Oftalmologia
      • Medellín, Colombia, 50021
        • Clinica de Oftalmologia Sandiego
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute
    • Texas
      • El Paso, Texas, United States, 79902
        • Southwest Eye Institute

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)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 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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