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J.S. Cohen, R.L. Gross, M.B. Sherwood, J.K. Cheetham, A. VanDenburgh, P. Bernstein, S.M. Whitcup; 2-Year Comparison of Bimatoprost with Timolol in Patients with Glaucoma or Ocular Hypertension . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2177.
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Purpose: To compare the long-term safety and efficacy of bimatoprost 0.03% (LUMIGAN® ) and timolol 0.5% in glaucoma and ocular hypertension patients Methods: Extension of a 1-year, randomized, double-masked trial to 2 years. After completion of the 1-year study, patients from selected sites were randomized to receive bimatoprost QD (n=167), bimatoprost BID (n=131), or timolol 0.5% BID (n=81) for an additional 12 months. Main outcome measures were mean IOP change from baseline (8 AM and 10 AM) and safety parameters. Results: IOP lowering efficacy with once or twice daily bimatoprost was maintained over 2 years. Mean IOP reductions were significantly greater with bimatoprost QD than with timolol at all visits (P<.001); from months 12 to 24, the 10 AM measurement was 7.4 – 8.2 mm Hg below baseline (month 0) in the bimatoprost QD group and 4.6 – 5.1 mm Hg below baseline in the timolol group. Mean IOPs among bimatoprost QD patients at 10 AM at months 12 and 24 were 17.1 mm Hg and 17.2 mm Hg, respectively. Mean IOPs among timolol patients at the same time points were 18.9 mm Hg and 19.1 mm Hg, respectively. There were no reports of increased iris pigmentation in any treatment group during this time period. Few patients discontinued treatment due to adverse events (bimatoprost QD, 3%; bimatoprost BID, 5.3%, and timolol, 4.9%). There was only 1 discontinuation due to hyperemia and that was from the bimatoprost BID group. Conclusions: Bimatoprost QD was consistently efficacious and well tolerated over 24 months of treatment with no evidence of decreased IOP-lowering efficacy. Bimatoprost QD was safe and well tolerated.
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