Efficacy of bimatoprost 0.03 percent in untreated glaucoma and ocular hypertension patients: results from a large community-based clinical trial.
PURPOSE: To evaluate the intraocular pressure- (IOP-) lowering efficacy of bimatoprost 0.03% (Lumigan, Allergan, Inc.) monotherapy in the treatment of patients with glaucoma or ocular hypertension not currently using ocular hypotensives. METHODS: Open-label, community-based, multicenter evaluation. Patients (n = 6767) who, according to their physicians, required IOP lowering were prescribed bimatoprost for 2 months. Subgroup analyses of the results, stratified by treatment history and use of concomitant medications, were performed. This report focuses on the subgroup of patients that was not being treated with antiglaucoma medications at baseline (n = 1946, 29%). All of these patients were placed on bimatoprost monotherapy. RESULTS: The mean IOP at the untreated baseline was 23.8 mmHg. Bimatoprost provided a mean IOP reduction of 7.5 mmHg (30%, p < 0.001) from baseline after 2 months of monotherapy. Further, bimatoprost allowed patients to achieve low target pressures. For example, 41.5% of patients achieved target IOPs of < or =15 mmHg after 2 months of bimatoprost monotherapy, and 75.8% of patients reached IOPs of < or =18 mmHg. The most commonly reported adverse event was conjunctival hyperemia (7.9%). CONCLUSION: Bimatoprost monotherapy was well tolerated and reduced IOP by an average of 30% in a large population of untreated patients.