Phase 3 Randomized 3-Month Trial with an Ongoing 3-Month Safety Extension of Fixed-Combination Brinzolamide 1%/Brimonidine 0.2%
Phase 3 Randomized 3-Month Trial with an Ongoing 3-Month Safety Extension of Fixed-Combination Brinzolamide 1%/Brimonidine 0.2%
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DOI：
10.1089/jop.2012.0235
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发表时间：
2013-04-01
影响因子：
2.3
通讯作者：
Goode, Stephen M.
中科院分区：
文献类型：
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作者：
Nguyen, Quang H.;McMenemy, Matthew G.;Goode, Stephen M.
目的：比较1%布林唑胺和0.2%布林唑胺(BBFC)与其配伍药物布林唑胺和布莫尼定对开角型青光眼或高眼压患者的降眼压效果。患者和方法：在这项为期3个月的多中心、双盲、平行、为期3个月的研究中，符合条件的患者被随机分为3组，在洗脱一段时间后，每天3次使用布林唑胺、布林唑胺或布莫尼定治疗。这项研究的主要目的是确定BBFC的降眼压效果是否优于单独使用布林唑胺和单独使用布莫尼定。分别于研究用药后2周、6周和3个月的上午8：00、10：00、下午3：00和下午5：00进行眼压测定。结果：共纳入690例患者，其中615例完成了为期3个月的随访。在评估的4个时间点，3个治疗组的基线平均眼压水平相似。在3个月的主要终点，BBFC组的平均眼压显著低于布林唑胺组和布莫尼定组(P
Purpose: This study compared the intraocular pressure (IOP)-lowering efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) with that of its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension.Patients and Methods: In this phase 3, multicenter, double-masked, parallel-group, 3-month study with a 3-month safety extension, eligible patients were randomized 1: 1: 1 to treatment with BBFC, brinzolamide, or brimonidine thrice daily after a washout period, during which any IOP-lowering medications were discontinued. The primary objectives of this study were to determine whether the IOP-lowering efficacy of BBFC was superior to that of brinzolamide alone and, separately, of brimonidine alone. IOP was assessed at 8: 00 AM, 10: 00 AM, 3: 00 PM, and 5: 00 PM at 2 weeks, 6 weeks, and 3 months after study drug initiation.Results: A total of 690 patients were enrolled in the study, and 615 completed the 3-month visit. Baseline mean IOP levels were similar among the 3 treatment groups at each of the 4 time points assessed. At the 3-month primary endpoint, mean IOP of the BBFC group was significantly lower than that of either the brinzolamide group or the brimonidine group (P