Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 81
- Primary Endpoint
- Change From Baseline in Average Intraocular Pressure (IOP)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Intervention: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (Drug)
latanoprost 0.005% ophthalmic solution
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Intervention: latanoprost 0.005% ophthalmic solution (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Average Intraocular Pressure (IOP)
Time Frame: Baseline, Month 3
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).
Secondary Outcomes
- Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading(Baseline, Month 3)
- Change From Baseline IOP(Baseline, Month 3)
- Percentage of Patients Reaching a Predefined Target Pressure Threshold(Baseline, Month 3)
- Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading(Baseline, Month 3)