Lifitegrast治疗干眼病:第三阶段的结果,随机,双盲,安慰剂对照试验(OPUS-3)。

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荷兰EJ、限度J, Karpecki点,尼科尔斯KK,杰克逊,萨尔K,陶贝尔J,罗伊·M Raychaudhuri, Shojaei

Lifitegrast治疗干眼病:第三阶段的结果,随机,双盲,安慰剂对照试验(OPUS-3)。

眼科学。2017年1月,124 (1):53-60。doi: 10.1016 / j.ophtha.2016.09.025。Epub 2016年10月27日。

PubMed ID

28079022 (在PubMed

]

文摘

目的:Lifitegrast是一个淋巴细胞关联antigen-1拮抗剂发达减少炎症干眼病(d)。我们报告的结果OPUS-3 (NCT02284516),第三阶段研究评估lifitegrast与安慰剂的疗效和安全性与d参与者。设计:Twelve-week、III期随机、双盲、多中心、安慰剂对照研究。参与者:> / = 18岁成人Schirmer撕裂试验(没有麻醉)> / = 1 / = 2.0(0 - 4规模),眼睛干涩的分数(EDS) > / = 40(0 - 100视觉模拟量表(血管)),30天内人工眼泪和历史使用的条目。方法:14天安慰剂后试车,参与者被随机1:1 lifitegrast眼科解决方案或安慰剂5.0%每天两次为84天。主要结果测量:主要疗效终点是改变从基线到84天。关键次要疗效终点变化从基线到42天在EDS和14。其他次要疗效终点包括额外的血管项目(燃烧/刺、痒、异物感眼睛不适,畏光、疼痛),眼部不适得分(ODS)和安全/耐受性lifitegrast和安慰剂。结果:在这项研究中,711名参与者被随机分配:安慰剂,356;355 lifitegrast(意向处理(ITT)人口)。 At day 84, lifitegrast-treated participants experienced significantly greater improvement from baseline in EDS versus those receiving placebo (treatment effect [TE], 7.16; 95% confidence interval [CI], 3.04-11.28; P = 0.0007). Mean changes from baseline in EDS also significantly favored lifitegrast on days 42 (TE, 9.32; 95% CI, 5.44-13.20; P < 0.0001) and 14 (TE, 7.85; 95% CI, 4.33-11.37; P < 0.0001). No statistically significant differences were observed in ODS between treatment groups at days 84, 42, or 14. A greater improvement was observed in lifitegrast-treated participants at day 42 in itching (nominal P = 0.0318), foreign body sensation (nominal P = 0.0418), and eye discomfort (P = 0.0048) versus participants receiving placebo. Most treatment-emergent adverse events were mild to moderate in severity; no serious ocular adverse events were reported. CONCLUSIONS: Lifitegrast significantly improved symptoms of eye dryness, as measured by EDS, versus placebo in participants with DED. Improvement in EDS was observed as early as day 14. Lifitegrast appeared well tolerated.

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药物

Lifitegrast