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
Verified date | November 2023 |
Source | Laboratoires Thea |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Laboratoires Thea |
United States, Colombia,
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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