在日本的长期安全性和有效性Latanoprostene Bunod 0.024%受试者与开角青光眼或眼部高血压:木星的研究。

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森K, Vittitow杰,发现RN, Araie M

在日本的长期安全性和有效性Latanoprostene Bunod 0.024%受试者与开角青光眼或眼部高血压:木星的研究。

难以其他。2016年9月,33(9):1612 - 27所示。doi: 10.1007 / s12325 - 016 - 0385 - 7。Epub 2016 7月25。

PubMed ID

27457469 (在PubMed

]

文摘

简介:Latanoprostene bunod (LBN)是一种新型的一氧化氮(NO)捐赠前列腺素F2alpha模拟。我们评估了长期安全性和眼内压(IOP)降低功效LBN眼科解决方案的0.024%在1年日本主题与开角青光眼(OAG)或眼部高血压(OHT)。方法:这是一个单臂,多中心、非盲、临床研究。受试者20岁以上OAG的诊断或OHT灌输一滴LBN眼科解决方案影响眼睛的0.024% (s)每天一次在晚上为52周,每4周进行评估。安全评估包括生命体征、全面的眼科检查,和治疗诱发不良事件(AEs)。绝对和基线的百分比降低IOP也确定。结果:130名受试者中,121名(93.1%)完成了这项研究。平均年龄为62.5岁,平均(标准差)基线眼压是19.6(2.9)和(2.6)18.7毫米汞柱的研究和治疗眼睛的眼睛,分别。总的来说,76/130(58.5%)和78/126(61.9%)的主题经历了> / = 1 AEs研究和治疗眼睛的眼睛,分别。在这两个研究和治疗眼睛的眼睛,最常见的AEs结膜充血,增长睫毛,眼睛刺激性,和眼睛疼痛。 At 52 weeks, 9% of treated eyes had an increase in iris pigmentation compared with baseline based on iris photographs. No safety concerns emerged based on vital signs or other ocular assessments. Mean reductions from baseline in IOP of 22.0% and 19.5% were achieved by week 4 in study and treated fellow eyes, respectively. These reductions were maintained through week 52 (P < 0.001 vs. baseline at all visits). CONCLUSION: Once daily LBN ophthalmic solution 0.024% was safe and well-tolerated in Japanese subjects with OAG or OHT when used for up to 1 year. Long-term treatment with LBN ophthalmic solution 0.024% provided significant and sustained IOP reduction. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01895972. FUNDING: Bausch & Lomb, Inc. a division of Valeant Pharmaceuticals International Inc.

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Latanoprostene bunod