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DA Lee, R Gross, TK MundorfLumigan Early Experience Study Group; Efficacy and Safety of Bimatoprost 0.03% (LUMIGAN) in a Large-Scale, Open-Label Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2002;43(13):4105.
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Purpose: To evaluate the safety and efficacy of bimatoprost 0.03% for the treatment of glaucoma and ocular hypertension in the "real-life" clinical practices of physicians throughout the United States and Puerto Rico. Method: Two-month, open-label, non-comparative surveillance trial. Included patients had a diagnosis of glaucoma or ocular hypertension and were in need of additional intraocular pressure (IOP)-lowering or were intolerant of other ocular hypotensive medications. Results: 6767 patients were enrolled at 1439 clinical sites. Physicians prescribed bimatoprost as monotherapy for patients not using IOP-lowering medications at baseline (n=1946, 28.8%), as adjunctive therapy (n=2640, 39.0%), or as replacement therapy (n=2117, 31.3%). After 2 months of bimatoprost therapy, the mean IOP reduction in patients newly diagnosed with glaucoma was 7.9 mm Hg (30.7%, P<.001). Among patients who added bimatoprost to their ongoing treatment regimens, the mean additional IOP reduction with bimatoprost was 5.0 mm Hg (21.3%, P<.001). After 2 months of bimatoprost replacement therapy, the mean IOP reduction from baseline on the previous therapy was 4.2 mm Hg (18.6%, P<.001). Patients were significantly more likely to achieve every target level of IOP from < 12 to < 18 mm Hg after 2 months of bimatoprost therapy than at baseline (P<.001). For example, 32.5% of patients achieved a target of <15 mm Hg at the month 2 evaluation, compared with 5.6% of patients at baseline (P<.001). Conclusion: Bimatoprost is highly effective as monotherapy, adjunctive therapy, and replacement therapy for glaucoma and ocular hypertension patients in "real-life" clinical practice. Bimatoprost allows patients to reach low target IOP levels.
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