Wang Ningli, Lu Da-Wen, Pan Yingzi, Astakhov Yury, Iureva Tatyana, Adewale Adeniyi, Walker Thomas M
Beijing Tongren Eye Center, Beijing, People's Republic of China.
Tri-Service General Hospital, Taipei, Taiwan.
Clin Ophthalmol. 2020 Jan 23;14:221-230. doi: 10.2147/OPTH.S231402. eCollection 2020.
To demonstrate that the intraocular pressure (IOP)-lowering efficacy of a twice-daily brinzolamide 10 mg/mL (BRINZ)/brimonidine 2 mg/mL (BRIM) fixed-dose combination (BBFC) was non-inferior to its individual components (BRINZ+BRIM) dosed concomitantly in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Safety was also evaluated.
This was a Phase III, multicenter, observer-masked study in patients from China, Russia and Taiwan. Patients aged ≥18 years with a mean IOP ≥21 mmHg and ≤36 mmHg in the same eye after washout of other IOP-lowering medications were included. Eligible patients were randomized (1:1) to receive BBFC or BRIZ+BRIM eye drops twice daily for 3 months. The primary endpoint was the mean change in diurnal IOP (averaged over 09:00, +2 h, and +7 h) from baseline to Month 3. Adverse events (AEs) were recorded throughout the study.
The per-protocol set included 349 patients (BBFC, n=172; BRINZ+BRIM, n=177). The mean±standard deviation diurnal IOP at baseline was 24.6±2.66 mmHg in both groups. At Month 3, the least square mean±standard error change in diurnal IOP from baseline was -7.2±0.34 mmHg and -7.3±0.34 mmHg with BBFC and BRINZ+BRIM, respectively (between-group difference: 0.1 mmHg [95% CI -0.5, 0.7]). In the BBFC and BRINZ+BRIM groups, 53.3% and 55.0% of patients achieved a diurnal IOP <18 mmHg, and 43.2% and 37.4% of patients, respectively, achieved a mean diurnal IOP reduction >30% from baseline at Month 3. Ocular AEs were reported in 28.7% (BBFC) and 22.5% (BRINZ+BRIM) of patients; conjunctival hyperemia was the most frequent ocular AE (BBFC, 6.4%; BRINZ+BRIM, 6.8%). Non-ocular AEs were reported in 32.4% (BBFC) and 30.4% (BRINZ+BRIM) of patients.
The study findings demonstrate that the efficacy of twice-daily BBFC was non-inferior to BRINZ+BRIM in patients with OAG/OHT. The safety profile of BBFC was similar to that of BRINZ+BRIM.
证明每天两次使用10mg/mL布林佐胺（BRINZ）/2mg/mL溴莫尼定（BRIM）固定剂量复方制剂（BBFC）降低开角型青光眼（OAG）或高眼压症（OHT）患者眼压（IOP）的疗效不劣于其单独成分同时给药（BRINZ+BRIM）。同时评估安全性。
这是一项针对来自中国、俄罗斯和台湾患者的III期多中心、观察者设盲研究。纳入年龄≥18岁，在停用其他降眼压药物洗脱期后，同一只眼睛平均IOP≥21mmHg且≤36mmHg的患者。符合条件的患者被随机分组（1:1），每天两次接受BBFC或BRIZ+BRIM滴眼液治疗，为期3个月。主要终点是从基线到第3个月日间IOP的平均变化（09:00、+2小时和+7小时的平均值）。在整个研究过程中记录不良事件（AE）。
符合方案集包括349例患者（BBFC组，n = 172；BRINZ+BRIM组，n = 177）。两组基线时的平均±标准差日间IOP为24.6±2.66mmHg。在第3个月时，BBFC组和BRINZ+BRIM组从基线开始的日间IOP最小二乘均值±标准误变化分别为-7.2±0.34mmHg和-7.3±0.34mmHg（组间差异：0.1mmHg [95%CI -0.5, 0.7]）。在BBFC组和BRINZ+BRIM组中，分别有53.3%和55.0%的患者日间IOP <18mmHg，在第3个月时，分别有43.2%和37.4%的患者日间平均IOP较基线降低>30%。28.7%（BBFC组）和22.5%（BRINZ+BRIM组）的患者报告了眼部AE；结膜充血是最常见的眼部AE（BBFC组，6.4%；BRINZ+BRIM组，6.8%）。32.4%（BBFC组）和30.4%（BRINZ+BRIM组）的患者报告了非眼部AE。
研究结果表明，每天两次使用BBFC治疗OAG/OHT患者的疗效不劣于BRINZ+BRIM。BBFC的安全性与BRINZ+BRIM相似。
