Phase 4
Completed N=81
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Glaucoma, Open-Angle
Source: ClinicalTrials.gov NCT01243567 ↗
Enrolled (actual)
81
Serious AEs
1.2%
Results posted
Feb 2013
Primary outcomePrimary: Change From Baseline in Average Intraocular Pressure (IOP) — 28.4; 28.5; -13.5; -11.4 Millimeters of Mercury (mmHg)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Intraocular Pressure (IOP) |
28.4; 28.5; -13.5; -11.4 | — |
| SECONDARY Change From Baseline IOP |
29.7; 29.6; 28.7; 29.0; 26.8; 26.8 | — |
| SECONDARY Percentage of Patients Reaching a Predefined Target Pressure Threshold |
97.7; 100.0; 90.7; 86.8; 74.4; 47.4 | — |
| SECONDARY Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading |
30.4; 30.3; -15.3; -12.9 | — |
| SECONDARY Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading |
26.2; 26.5; -11.8; -9.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01243567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.