PURPOSE To determine the intraocular pressure (IOP)-lowering effect of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) over a 24-hour period. DESIGN Prospective, multicenter, double-masked, parallel-group clinical trial conducted at 16 academic and nonacademic sites in the United States. PARTICIPANTS Subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT) aged ≥18 years with mean baseline IOP measurements in at least 1 eye of ≥21 and <28 mmHg. METHODS Duplicate mean pneumatonometer IOP measurements were collected every 2 hours over a 24-hour period in controlled light conditions in overnight facilities. Daytime (8 am-8 pm) and nocturnal (10 pm-6 am) IOP measurements were collected in a sitting or supine position, respectively. Baseline 24-hour IOP was measured in untreated subjects after a washout (up to 4 weeks) and eligibility phase. After the baseline visit, participants were randomized 1:1 to receive masked BBFC or vehicle, 1 drop 3 times daily (8 am, 3 pm, and 10 pm) for 4 weeks. At week 4, IOP measurements were repeated in both groups under the same conditions. MAIN OUTCOME MEASURE Mean change from baseline in 24-hour IOP at week 4. RESULTS Of 125 participants randomized, 123 (98%; BBFC, n = 62; vehicle, n = 61) completed the study. No subjects randomized to BBFC discontinued the study. At week 4, BBFC-treated eyes had significantly reduced mean 24-hour IOP vs. vehicle (least squares mean difference [95% confidence interval]: -2.5 [-3.3, -1.7]; P < 0.001); daytime (-3.4 [-4.3, -2.6]; P < 0.001) and nocturnal (-1.2 [-2.3, 0.0]; P = 0.053) reductions were observed. Mean change from baseline was significantly different between BBFC- and vehicle-treated eyes at all daytime points and 3 of 5 nocturnal time points (10 pm, 12 am, and 6 am; secondary end point). The frequency of adverse events was similar between treatment groups; in the BBFC arm, ocular hyperemia, corneal abrasion, and dysgeusia were the most frequently reported, consistent with events described in the drug label. CONCLUSIONS This large, multicenter study of 24-hour IOP control with BBFC met its primary end point; BBFC demonstrated significantly superior 24-hour IOP-lowering efficacy versus vehicle after 4 weeks of 3-times-daily treatment in subjects with OAG or OHT.

中文翻译：

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固定剂量联合使用24％眼内压控制1％的Brinzolamide / 0.2％的溴莫尼定：一项多中心随机试验。

目的确定在24小时内固定组合使用1％溴苯甲酰胺/0.2%溴莫尼定（BBFC）的眼内压（IOP）降低效果。设计在美国的16个学术和非学术场所进行的前瞻性，多中心，双掩盖，平行组临床试验。参与者年龄≥18岁的开角型青光眼（OAG）或高眼压（OHT）的受试者，其至少1只眼睛的≥21和<28 mmHg的平均基线IOP测量值。方法在隔夜设施中，在受控的光照条件下，每24小时每2小时收集两次重复的平均气压计IOP测量值。白天（上午8点至晚上8点）和夜间（晚上10点至下午6点）的IOP测量值分别以坐姿或仰卧位进行。在冲洗（长达4周）和入选阶段后，对未经治疗的受试者进行24小时基线IOP的测量。基线访视后，将参与者按1：1的比例随机分配接受遮罩的BBFC或媒介，每天1次，共3次（上午8点，下午3点和晚上10点），持续4周。在第4周，两组在相同条件下重复IOP测量。主要观察指标第4周的24小时IOP相对于基线的平均变化。结果在125位随机参与者中，有123位（98％； BBFC，n = 62；媒介物，n = 61）完成了研究。没有随机分组为BBFC的受试者终止研究。在第4周时，用BBFC治疗的眼睛与车辆相比，平均24小时IOP显着降低（最小二乘均方差[95％置信区间]：-2.5 [-3.3，-1.7]； P <0.001）；白天（-3.4 [-4.3，-2.6]; P <0.001）和夜间（-1.2 [-2.3，0.0]; P = 0。053）观察到减少。在所有白天点和5个夜间时间点中的3个（晚上10点，12点和6点；次要终点）中，BBFC眼和媒介物治疗眼的基线相对于基线的平均变化均存在显着差异。治疗组之间不良事件的发生频率相似。在BBFC臂中，眼部充血，角膜擦伤和消化不良是最常报告的，与药物标签中所述的事件一致。结论BBFC对24小时IOP控制进行的大型，多中心研究达到了其主要终点。在患有OAG或OHT的受试者中，每日3次每天治疗4周后，BBFC表现出明显优于24小时的IOP降低功效。在所有白天点和5个夜间时间点中的3个（晚上10点，12点和6点；次要终点），BBFC眼和媒介物治疗眼的基线平均变化显着不同。治疗组之间不良事件的发生频率相似。在BBFC组中，眼充血，角膜擦伤和消化不良是最常报告的，与药物标签中所述的事件一致。结论BBFC对24小时IOP控制进行的大型，多中心研究达到了其主要终点。在患有OAG或OHT的受试者中，每日3次每天治疗4周后，BBFC表现出明显优于24小时的IOP降低功效。在所有白天点和5个夜间时间点中的3个（晚上10点，12点和6点；次要终点），BBFC眼和媒介物治疗眼的基线平均变化显着不同。治疗组之间不良事件的发生频率相似。在BBFC组中，眼充血，角膜擦伤和消化不良是最常报告的，与药物标签中所述的事件一致。结论BBFC对24小时IOP控制进行的大型，多中心研究达到了其主要终点。在患有OAG或OHT的受试者中，每日3次每天治疗4周后，BBFC表现出明显优于24小时的IOP降低功效。和味觉障碍是最常报告的，与药物标签中所述的事件一致。结论BBFC对24小时IOP控制进行的大型，多中心研究达到了其主要终点。在患有OAG或OHT的受试者中，每日3次每天治疗4周后，BBFC表现出明显优于24小时的IOP降低功效。和味觉障碍是最常报告的，与药物标签中所述的事件一致。结论BBFC对24小时IOP控制进行的大型，多中心研究达到了其主要终点。在患有OAG或OHT的受试者中，每日3次每天治疗4周后，BBFC表现出明显优于24小时的IOP降低功效。