Clinical trial

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

NCT05397600

Name

LT4032-302

Description

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

Trial arms

Trial start

2022-06-22

Estimated PCD

2024-03-07

Trial end

2024-03-07

Status

Completed

Phase

Early phase I

Treatment

Bimatoprost Ophthalmic

Eyedrops

Arms:

Lumigan, T4032

Size

684

Primary endpoint

Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.

up to Week12

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 684, 'type': 'ACTUAL'}}

Updated at

2024-03-20

1 organization

1 product

2 indications

Organization

Product

Indication

Indication