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NCT05397600 Clinical Trial

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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05397600
Other study ID # LT4032-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 22, 2022
Est. completion date March 7, 2024

Study information
Verified date November 2023
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 684
Est. completion date March 7, 2024
Est. primary completion date March 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost Ophthalmic
Eyedrops

Locations
Country Name City State
Colombia Clínica Oftalmológica del Caribe Barranquilla
Colombia Fundación Oftalmológica Nacional (FUNDONAL) Bogotá
Colombia Clinica de Oftalmologia de Cali SA Cali
Colombia Fundación Oftalmológica de Santander FOSCAL Floridablanca
Colombia Instituto Nacional de Investigacion en Oftalmologia Medellin
Colombia Clinica de Oftalmologia Sandiego Medellín
United States Southwest Eye Institute El Paso Texas
United States Scheie Eye Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Countries where clinical trial is conducted

United States,  Colombia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP. 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
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