Status:
COMPLETED
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Lead Sponsor:
Laboratoires Thea
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
Eligibility Criteria
Inclusion
- Informed consent dated and signed.
- Both eyes diagnosed open-angle glaucoma or ocular hypertension
Exclusion
- 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
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2024
Estimated Enrollment :
684 Patients enrolled
Trial Details
Trial ID
NCT05397600
Start Date
June 22 2022
End Date
March 7 2024
Last Update
July 18 2024
Active Locations (64)
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1
Arizona Eye Center - Chandler
Chandler, Arizona, United States, 85224-0002
2
Eye Physicians & Surgeons of Arizona - Glendale Office
Glendale, Arizona, United States, 85306
3
Arizona Glaucoma Specialists - Phoenix
Phoenix, Arizona, United States, 85050
4
Walman Eye Center - Sun City
Sun City, Arizona, United States, 85351-3019