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

Phase 3CompletedNCT04898387

Laboratoires Thea554 enrolled

Overview

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

Efficacy Parameters IOP assessment in each eye

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

554

Conditions

Ocular Hypertension Glaucoma

Interventions

Bimatoprost Timolol (T4030)COMBINATION_PRODUCT

Eye drop

Bimatoprost Timolol (Ganfort)COMBINATION_PRODUCT

Eye drop

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Center Vereya EOOD

Stara Zagora, Bulgaria

Outcomes

Primary Outcomes

IOP assessment

The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP

Time frame: Week 12

Secondary Outcomes

Ocular Sign

Ocular sign will be assessed through slit lamp examination at each visits

Time frame: Week 6 Week 12

Data from ClinicalTrials.gov

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