Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.
Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jpn J Ophthalmol. 2021 Mar;65(2):295-305. doi: 10.1007/s10384-020-00796-3. Epub 2021 Feb 16.
To assess the 12-month efficacy and safety of fixed-combination brimonidine tartrate 0.2%/timolol maleate 0.5% (FCBT) with or without bimatoprost 0.01% (BIM) in primary open-angle glaucoma (POAG), including normal-tension glaucoma (NTG).
Prospective, multicenter, open-label study.
FCBT was self-administered twice daily after applicable washout (study eye). Intraocular pressure (IOP) was measured at baseline and months 1, 3, 6, 9, and 12. BIM could be added for IOP ≥ 21 mmHg, IOP reduction from baseline < 20%, or the investigator deemed it necessary. Primary endpoint: mean (11-a.m.) month-12 IOP change from baseline. Secondary endpoints included mean IOP changes from baseline at other visits, median time to achieving and patients (%) achieving target IOP reduction with FCBT, and visual field (VF) progression rate over 12 months. Safety was assessed at each visit.
Of 118 eyes with POAG (NTG, n = 93), 87 used FCBT; 31 required FCBT + BIM. Mean IOP changes from baseline (16.8 and 15.3 mmHg) to month 12 were - 4.1 mmHg (FCBT, n = 62) and - 3.5 mmHg (FCBT + BIM, n = 15), respectively (both P < 0.0001). Patients who achieved target IOP reduction with FCBT did so in 1 month (median). VF progression rates were 0.17%/year (FCBT, P = 0.8367) and - 0.08%/year (FCBT + BIM, P = 0.9410). Ocular treatment-emergent adverse events occurred in 42.5% (FCBT) and 71.0% (FCBT + BIM) of patients; most were mild and included ocular hyperemia (9.2% and 41.9%, respectively).
Despite low mean baseline IOP, ≥ 20% IOP reduction from baseline persisted over 12 months with FCBT and FCBT + BIM, without clinically significant VF progression. Tolerability was consistent with reported drug safety profiles.
评估复方溴莫尼定酒石酸盐 0.2%/马来酸噻吗洛尔 0.5%（FCBT）联合或不联合贝美前列素 0.01%（BIM）在原发性开角型青光眼（POAG），包括正常眼压青光眼（NTG）中的 12 个月疗效和安全性。
前瞻性、多中心、开放标签研究。
FCBT 在适当的洗脱期后（研究眼）每日两次自我给药。在基线和第 1、3、6、9 和 12 个月测量眼内压（IOP）。如果 IOP≥21mmHg、IOP 从基线降低<20%，或者研究者认为有必要，可以加用 BIM。主要终点：从基线到第 12 个月的平均（上午 11 点）月 IOP 变化。次要终点包括其他就诊时从基线的平均 IOP 变化、达到目标 IOP 降低的时间中位数和接受 FCBT 的患者（%）、12 个月时的视野（VF）进展率。每次就诊时评估安全性。
在 118 只患有 POAG（NTG，n=93）的眼中，87 只使用了 FCBT；31 只需要 FCBT+BIM。从基线到第 12 个月的平均 IOP 变化（FCBT，n=62）分别为-4.1mmHg 和-3.5mmHg（FCBT+BIM，n=15）（均 P<0.0001）。接受 FCBT 治疗达到目标 IOP 降低的患者在 1 个月内达到（中位数）。VF 进展率分别为 0.17%/年（FCBT，P=0.8367）和-0.08%/年（FCBT+BIM，P=0.9410）。42.5%（FCBT）和 71.0%（FCBT+BIM）的患者发生眼部治疗引起的不良事件；大多数为轻度，包括眼部充血（分别为 9.2%和 41.9%）。
尽管平均基线 IOP 较低，但 FCBT 和 FCBT+BIM 持续 12 个月，IOP 从基线降低≥20%，且无临床意义的 VF 进展。耐受性与报告的药物安全性一致。
