Objective: To assess the efficacy and tolerability of a fixed combination of bimatoprost and timolol (BTFC) in a large patient sample in a clinical setting.

Methods: In this multicenter, observational, noncontrolled, open-label study, patients (n = 1862) with primary open-angle glaucoma or ocular hypertension were treated with BTFC. Assessments were made at baseline, six weeks, and three months.

Results: Prior to starting BTFC, 92.3% of patients were taking other ocular hypotensive medications. In the overall group at three months, mean intraocular pressure was reduced from baseline (21.7 ± 4.5 mmHg and 21.8 ± 4.9 mmHg for the right and left eye, respectively) to 16.1 ± 3.0 mmHg for each eye (P < 0.0001). The majority of patients (92%) reported no adverse events. The most commonly reported adverse events (in >1% of patients) were eye irritation, and ocular and conjunctival hyperemia. Adherence to treatment was generally better than (35.4%) or the same as (57.5%) with prior therapy. BTFC tolerability was rated as excellent or good by 92.3% of physicians and 85.8% of patients.

Conclusions: In a large group of patients with primary open-angle glaucoma or ocular hypertension, treatment with BTFC was associated with consistent reductions in IOP, improved adherence to treatment, and good tolerability.