A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma

被引:265
作者
Noecker, RS
Dirks, MS
Choplin, NT
Bernstein, P
Batoosingh, AL
Whitcup, SM
机构
[1] Univ Arizona, Tucson, AZ USA
[2] Black Hills Reg Eye Inst, Rapid City, SD USA
[3] Eye Care San Diego, San Diego, CA USA
[4] Allergan Pharmaceut Inc, Irvine, CA USA
关键词
D O I
10.1016/S0002-9394(02)01827-5
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
PURPOSE: To compare the intraocular pressure (IOP)lowering efficacy and safety of topical bimatoprost 0.03% with latanoprost 0.005%. DESIGN: Multicenter, randomized, investigator, masked clinical trial. METHODS: After washout of glaucoma medications, ocular hypertension or glaucoma patients were randomly assigned to once,daily bimatoprost 0.03% (n = 133) or latanoprost 0.005% (n = 136) for 6 months. The primary outcome measure was mean change from based line IOP (8 AM, 12 PM, 4 PM). Secondary measures included mean IOP, ophthalmologic examination, ad, verse events, and the percentage of patients reaching specific target IOPs. RESULTS: Mean change from baseline IOP was significantly greater for bimatoprost patients than for latanoprost patients at all measurements on each study visit; 1.5 mm Hg greater at 8 AM (P < .001), 2.2 mm Hg greater at 12 PM (P < .001), and 1.2 mm Hg greater at 4 PM (P = .004) at month 6. At the end of the study, the percentage of patients achieving a greater than or equal to20% IOP decrease was 69% to 82% with bimatoprost and 50% to 62% with latanoprost (P less than or equal to .003). In addition, the distribution of patients achieving target pressures in each range (less than or equal to13 to less than or equal to 15 mm Hg, > 15 to less than or equal to 18 mm Hg, and > 18 mm Hg) showed that bimatoprost produced lower target pressures compared with latanoprost at all times measured (P less than or equal to .026). Few patients were discontinued for adverse events (6 on bimatoprost; 5 on latanoprost). On ophthalmologic examination, conjunctival hyperemia (P < .001) and eyelash growth (P = .064) were more common in bimatoprost patients. CONCLUSIONS: Bimatoprost is more effective than latanoprost in lowering IOP. Both drugs were well tolerated, with few discontinuations for adverse events.
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页码:55 / 63
页数:9
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