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

• Status: Not yet recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Thea
• Treatments: Bimatoprost

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