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Trial record 1 of 1 for:    Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.
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Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05397600
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

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

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Bimatoprost Ophthalmic Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: T4032 Drug: Bimatoprost Ophthalmic
Eyedrops
Active Comparator: Lumigan Drug: Bimatoprost Ophthalmic
Eyedrops


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05397600


Contacts
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Contact: Corentin LECAMUS +33473981436 Corentin.LECAMUS@theapharma.com

Locations
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United States, Pennsylvania
Scheie Eye Institute Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Eydie Miller-Ellis         
United States, Texas
Southwest Eye Institute Recruiting
El Paso, Texas, United States, 79902
Contact: Louis Alpern         
Colombia
Clínica Oftalmológica del Caribe Not yet recruiting
Barranquilla, Colombia, 80001
Contact: Jose Rodriguez         
Fundación Oftalmológica Nacional (FUNDONAL) Not yet recruiting
Bogotá, Colombia, 110231
Contact: Sandra Belalcazar Rey         
Clinica de Oftalmologia de Cali SA Not yet recruiting
Cali, Colombia, 760001
Contact: Edgar Lozano         
Fundación Oftalmológica de Santander FOSCAL Not yet recruiting
Floridablanca, Colombia, 681004
Contact: Jaun Camilo Parra Restrepo         
Instituto Nacional de Investigacion en Oftalmologia Not yet recruiting
Medellin, Colombia, 50024
Contact: Catalina Ramirez         
Clinica de Oftalmologia Sandiego Not yet recruiting
Medellín, Colombia, 50021
Contact: Santiago Arango Velez         
Sponsors and Collaborators
Laboratoires Thea
More Information
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Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT05397600    
Other Study ID Numbers: LT4032-302
First Posted: May 31, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Bimatoprost
Antihypertensive Agents