Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.

LT4030-301

To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.

2021-03-26

2023-04-13

2023-05-30

Completed

Early phase I

554

Inclusion Criteria: * Informed consent signed and dated\* * Patient aged ≥18 years old * Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a * Both eyes with diagnosed ocular hypertension or open angle glaucoma Exclusion Criteria: * History of narrow angle and/or angle closure glaucoma * Advanced stage of glaucoma

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The 2 different treatment kits should be identical in external packaging in order to respect the masked evaluation for efficacy and safety.\n\nThe identity of the IMP given to each patient will not be known by the masked investigator', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 554, 'type': 'ACTUAL'}}

2023-07-21