Cambridge University Hospitals, Cambridge, UK.
Vision and Eye Research Unit, Anglia Ruskin University, Cambridge, UK.
BMJ Open. 2019 Apr 2;9(4):e024129. doi: 10.1136/bmjopen-2018-024129.
Bimatoprost-timolol (bimatoprost 0.03%-timolol 0.5% fixed-dose combination [FDC]) and tafluprost-timolol (tafluprost 0.0015%-timolol 0.5% FDC) eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservative-free (PF) prostaglandin and timolol FDC. The aim of this study was to investigate changes to ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or benzalkonium chloride (BAK)-preserved bimatoprost-timolol to PF tafluprost-timolol eye drops.
This was a 12-week, open-label, phase IV study.
Sixteen centres in Finland, Germany, Italy and the UK.
Patients with OH or OAG (IOP on medication ≤21 mm Hg), treated with PF or BAK-preserved bimatoprost-timolol for ≥4 weeks before screening, and presenting with conjunctival hyperaemia and ≥1 ocular symptom.
Patients were switched to PF tafluprost-timolol once daily in the treated eye(s).
The primary endpoints were change from screening to week 12 in conjunctival hyperaemia and worst ocular symptom. The secondary outcome measures were changes from screening in ocular signs (other than conjunctival hyperaemia) and symptoms at week 12.
Of 123 enrolled patients, 121 were included in the intention-to-treat dataset, of which all were Caucasian and 54.5% were female; 76 patients used BAK-preserved bimatoprost-timolol and 45 used PF drops. Conjunctival hyperaemia and severity of worst ocular symptom following switch to PF tafluprost-timolol significantly reduced from screening to week 12 in all patients (p<0.001). The percentage of patients with ocular signs and symptoms was significantly reduced at week 12 compared with screening (p<0.001). IOP was not affected by the change of treatment.
Switching from BAK-preserved or PF bimatoprost-timolol to tafluprost-timolol reduced both signs and symptoms of ocular surface disease with no clinically relevant effect on IOP.
EudraCT2014-005273-37; Results.
比马前列素-噻吗洛尔（0.03%比马前列素-0.5%固定剂量组合[FDC]）和他氟前列素-噻吗洛尔（0.0015%他氟前列素-0.5%FDC）滴眼剂是目前唯一可作为无防腐剂（PF）前列腺素和噻吗洛尔 FDC 的局部降眼压（IOP）治疗药物。本研究旨在探讨患有高眼压（OH）或开角型青光眼（OAG）的患者从 PF 或苯扎氯铵（BAK）保存的比马前列素-噻吗洛尔转为 PF 他氟前列素-噻吗洛尔滴眼剂时，眼部体征和症状的变化。
这是一项为期 12 周、开放标签、IV 期研究。
芬兰、德国、意大利和英国的 16 个中心。
患有 OH 或 OAG（用药后 IOP≤21mmHg）的患者，在筛选前至少使用 PF 或 BAK 保存的比马前列素-噻吗洛尔治疗 4 周，并伴有结膜充血和≥1 个眼部症状。
患者每天在治疗眼使用 PF 他氟前列素-噻吗洛尔一次。
主要终点是从筛选到第 12 周时结膜充血和最严重眼部症状的变化。次要终点是第 12 周时筛选时眼部体征（除结膜充血外）和症状的变化。
在 123 名入组患者中，121 名患者被纳入意向治疗数据集，其中所有患者均为白种人，54.5%为女性；76 名患者使用 BAK 保存的比马前列素-噻吗洛尔，45 名患者使用 PF 滴眼剂。所有患者（p<0.001）从筛选到第 12 周时，结膜充血和最严重眼部症状的严重程度在使用 PF 他氟前列素-噻吗洛尔后显著降低。与筛选相比，第 12 周时眼部体征和症状的患者比例显著降低（p<0.001）。IOP 不受治疗变化的影响。
从 BAK 保存或 PF 比马前列素-噻吗洛尔转换为他氟前列素-噻吗洛尔可同时减轻眼部表面疾病的体征和症状，对 IOP 无临床相关影响。
EudraCT2014-005273-37；结果。
