Hamilton Glaucoma Center and Shiley Eye Institute, University of California San Diego, San Diego, California.
North Bay Eye Associates Inc., Petaluma, California.
Ophthalmology. 2019 Aug;126(8):1095-1104. doi: 10.1016/j.ophtha.2018.10.040. Epub 2018 Nov 4.
To determine the intraocular pressure (IOP)-lowering effect of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) over a 24-hour period.
Prospective, multicenter, double-masked, parallel-group clinical trial conducted at 16 academic and nonacademic sites in the United States.
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.
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.
Mean change from baseline in 24-hour IOP at week 4.
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.
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.
确定固定剂量组合布林佐胺 1%/溴莫尼定 0.2%(BBFC)在 24 小时内的降眼压(IOP)效果。
在美国 16 个学术和非学术地点进行的前瞻性、多中心、双盲、平行组临床试验。
年龄在 18 岁及以上的开角型青光眼(OAG)或高眼压症(OHT)患者,至少有 1 只眼的基线平均 IOP 测量值≥21mmHg 且<28mmHg。
在夜间设施中,在受控光照条件下,每 2 小时采集 2 次平均眼压计 IOP 测量值,共 24 小时。日间(8am-8pm)和夜间(10pm-6am)IOP 测量值分别在坐姿或仰卧位进行。在洗脱(最长 4 周)和合格期后,未经治疗的受试者在基线时测量 24 小时 IOP。基线访视后,参与者以 1:1 的比例随机接受 BBFC 或载体,每日 3 次(8am、3pm 和 10pm)滴注,持续 4 周。在第 4 周,两组均在相同条件下重复 IOP 测量。
第 4 周 24 小时 IOP 从基线的平均变化。
在随机分配的 125 名参与者中,123 名(98%;BBFC 组,n=62;载体组,n=61)完成了研究。没有随机分配到 BBFC 的受试者退出了研究。第 4 周时,与载体相比,BBFC 治疗组的平均 24 小时 IOP 显著降低(最小二乘均值差值[95%置信区间]:-2.5[-3.3,-1.7];P<0.001);观察到日间(-3.4[-4.3,-2.6];P<0.001)和夜间(-1.2[-2.3,0.0];P=0.053)的显著降低。与载体治疗组相比,在所有日间时间点和 5 个夜间时间点中的 3 个(10pm、12am 和 6am;次要终点),BBFC 治疗组的 24 小时 IOP 从基线的变化均有显著差异。两组之间不良反应的频率相似;在 BBFC 组中,眼充血、角膜擦伤和味觉障碍是最常报告的,与药物标签中描述的事件一致。
这项针对 24 小时 IOP 控制的大型多中心 BBFC 研究达到了主要终点;在 OAG 或 OHT 患者中,每日 3 次治疗 4 周后,BBFC 显示出明显优于载体的 24 小时 IOP 降低效果。