Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
NCT05397600 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 684
Last updated 2024-07-18
Summary
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
Conditions
Interventions
- DRUG
-
Bimatoprost Ophthalmic
Eyedrops
Sponsors & Collaborators
-
Laboratoires Thea
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-22
- Primary Completion
- 2024-03-07
- Completion
- 2024-03-07
- FDA Drug
- Yes
Countries
- United States
- Canada
- Colombia
Study Locations
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