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

Thea Pharma

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost Ophthalmic

Study type: Interventional

Funder types: Industry

Identifiers

NCT05397600

LT4032-302

Details and patient eligibility

About

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

Enrollment: 684 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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684 participants in 2 patient groups

T4032

Experimental group

Treatment:

Drug: Bimatoprost Ophthalmic

Lumigan

Active Comparator group

Treatment:

Drug: Bimatoprost Ophthalmic