Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

Allergan81 enrolled

Overview

This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glaucoma, Open-Angle

Interventions

bimatoprost 0.03%/timolol 0.5% combination ophthalmic solutionDRUG

Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.

latanoprost 0.005% ophthalmic solutionDRUG

Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of primary open-angle glaucoma that has never been treated * Visual Acuity 20/60 or better in each eye Exclusion Criteria: * Eye surgery within 3 months * Any refractive eye surgery * Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease \[COPD\], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction \[heart attack\]) * Eye inflammation or eye infection within 3 months * Eye trauma within 6 months * Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study

Locations (2)

Unnamed facility

Coimbra, Portugal

Unnamed facility

Madrid, Spain

Outcomes

Primary Outcomes

Change From Baseline in Average Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).

Time frame: Baseline, Month 3

Secondary Outcomes

Change From Baseline IOP

IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).

Time frame: Baseline, Month 3

Percentage of Patients Reaching a Predefined Target Pressure Threshold

IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.

Time frame: Baseline, Month 3

Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading

IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.

Time frame: Baseline, Month 3

Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading

IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.

Data from ClinicalTrials.gov

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