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Abstract：
OBJECTIVE: To evaluate the long-term efficacy and safety of ripasudil-brimonidine fixed-dose combination (RBFC), a new intraocular pressure (IOP)-lowering medication for glaucoma and ocular hypertension (OHT).
METHODS: This prospective, multicentre (23 sites in Japan), open-label study enrolled patients with primary open-angle glaucoma (POAG), OHT or exfoliative glaucoma and assigned them to one of four combination therapy cohorts, based on previous treatment(s) received: prostaglandin (PG) analogue (Cohort 1); PG analogue and beta-adrenoceptor blocker (β-blocker) (Cohort 2); PG analogue, β-blocker and carbonic anhydrase inhibitor (Cohort 3); or other/no treatment (Cohort 4). After a ≥ 4-week screening period, eligible patients received twice-daily RBFC for 52 weeks in addition to the treatments they were already receiving. Efficacy was assessed by change in IOP from baseline through week 52. Adverse events and adverse drug reactions (ADRs) were monitored throughout.
RESULTS: In total, 179 patients from Cohort 1 (n = 48), Cohort 2 (n = 44), Cohort 3 (n = 41) and Cohort 4 (n = 46) entered the RBFC treatment period. For all cohorts, mean IOP was significantly reduced at 11:00 (2 h after instillation of RBFC) through week 52 with the changes from baseline at week 52 of - 2.7 to - 4.1 mmHg across cohorts; all p < 0.001. Common ADRs were conjunctival hyperaemia (58%), allergic conjunctivitis (18%) and blepharitis (17%), most of which were mild in severity.
CONCLUSIONS: These data demonstrated the long-term efficacy and safety of RBFC, both alone and in combination with other anti-glaucoma agents. RBFC may offer a new treatment option for the long-term management of glaucoma and OHT.
BACKGROUND: Japan Registry of Clinical Trials Identifier: jRCT2080225063.
UNASSIGNED: 17 February 2020.
METHODS: This prospective, multicentre (23 sites in Japan), open-label study enrolled patients with primary open-angle glaucoma (POAG), OHT or exfoliative glaucoma and assigned them to one of four combination therapy cohorts, based on previous treatment(s) received: prostaglandin (PG) analogue (Cohort 1); PG analogue and beta-adrenoceptor blocker (β-blocker) (Cohort 2); PG analogue, β-blocker and carbonic anhydrase inhibitor (Cohort 3); or other/no treatment (Cohort 4). After a ≥ 4-week screening period, eligible patients received twice-daily RBFC for 52 weeks in addition to the treatments they were already receiving. Efficacy was assessed by change in IOP from baseline through week 52. Adverse events and adverse drug reactions (ADRs) were monitored throughout.
RESULTS: In total, 179 patients from Cohort 1 (n = 48), Cohort 2 (n = 44), Cohort 3 (n = 41) and Cohort 4 (n = 46) entered the RBFC treatment period. For all cohorts, mean IOP was significantly reduced at 11:00 (2 h after instillation of RBFC) through week 52 with the changes from baseline at week 52 of - 2.7 to - 4.1 mmHg across cohorts; all p < 0.001. Common ADRs were conjunctival hyperaemia (58%), allergic conjunctivitis (18%) and blepharitis (17%), most of which were mild in severity.
CONCLUSIONS: These data demonstrated the long-term efficacy and safety of RBFC, both alone and in combination with other anti-glaucoma agents. RBFC may offer a new treatment option for the long-term management of glaucoma and OHT.
BACKGROUND: Japan Registry of Clinical Trials Identifier: jRCT2080225063.
UNASSIGNED: 17 February 2020.
摘要：
目的：评价利帕舒地尔-溴莫尼定固定剂量联合用药（RBFC）的长期疗效和安全性，一种用于青光眼和高眼压（OHT）的新型降眼压（IOP）药物。
方法：这种前瞻性，多中心（日本有23个站点），开放标签研究纳入原发性开角型青光眼（POAG）患者，OHT或剥脱性青光眼，并将其分配到四个联合治疗队列之一，根据以前接受的治疗：前列腺素（PG）类似物（队列1）;PG类似物和β-肾上腺素受体阻滞剂（β-受体阻滞剂）（队列2）;PG类似物，β-阻断剂和碳酸酐酶抑制剂(队列3);或其他/无治疗(队列4)。在≥4周的筛查期后，符合条件的患者除了已经接受的治疗外,还接受每天2次RBFC治疗,共52周.通过IOP从基线到第52周的变化来评估功效。全程监测不良事件和药物不良反应（ADR）。
结果：总计，队列1的179例患者（n=48），队列2（n=44），队列3(n=41)和队列4(n=46)进入RBFC治疗期。对于所有队列，在第52周期间,平均IOP在11:00时(滴注RBFC后2小时)显著降低,与第52周时的基线相比变化为-2.7至-4.1mmHg;所有p<0.001.常见的不良反应是结膜充血（58%），过敏性结膜炎（18％）和眼睑炎（17％），其中大多数是轻微的严重程度。
结论：这些数据证明了RBFC的长期疗效和安全性，单独和与其他抗青光眼药物联合使用。RBFC可能为青光眼和OHT的长期管理提供新的治疗选择。
背景：日本临床试验注册标识符：jRCT2080225063。
■2020年2月17日。
方法：这种前瞻性，多中心（日本有23个站点），开放标签研究纳入原发性开角型青光眼（POAG）患者，OHT或剥脱性青光眼，并将其分配到四个联合治疗队列之一，根据以前接受的治疗：前列腺素（PG）类似物（队列1）;PG类似物和β-肾上腺素受体阻滞剂（β-受体阻滞剂）（队列2）;PG类似物，β-阻断剂和碳酸酐酶抑制剂(队列3);或其他/无治疗(队列4)。在≥4周的筛查期后，符合条件的患者除了已经接受的治疗外,还接受每天2次RBFC治疗,共52周.通过IOP从基线到第52周的变化来评估功效。全程监测不良事件和药物不良反应（ADR）。
结果：总计，队列1的179例患者（n=48），队列2（n=44），队列3(n=41)和队列4(n=46)进入RBFC治疗期。对于所有队列，在第52周期间,平均IOP在11:00时(滴注RBFC后2小时)显著降低,与第52周时的基线相比变化为-2.7至-4.1mmHg;所有p<0.001.常见的不良反应是结膜充血（58%），过敏性结膜炎（18％）和眼睑炎（17％），其中大多数是轻微的严重程度。
结论：这些数据证明了RBFC的长期疗效和安全性，单独和与其他抗青光眼药物联合使用。RBFC可能为青光眼和OHT的长期管理提供新的治疗选择。
背景：日本临床试验注册标识符：jRCT2080225063。
■2020年2月17日。
