Lifitegrast眼科溶液5.0%和安慰剂治疗干眼病:随机III期OPUS-2研究的结果。

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陶贝尔J, Karpecki P, Latkany R,限度J,马特尔J, K萨尔,Raychaudhuri,史密斯V,地道桥西CP

Lifitegrast眼科溶液5.0%和安慰剂治疗干眼病:随机III期OPUS-2研究的结果。

眼科学。2015年12月,122(12):2423 - 31所示。doi: 10.1016 / j.ophtha.2015.08.001。Epub 2015年9月11日。

PubMed ID

26365210 (在PubMed

]

文摘

目的:Lifitegrast是一个整合素拮抗剂,减少T-cell-mediated炎症与干眼病(d)。我们报告OPUS-2的结果,一项III期研究评估的有效性和安全性lifitegrast与安慰剂治疗d。设计:12周,多中心、随机、前瞻性,双盲,安慰剂对照的临床试验。参与者:> / = 18岁成年人30天内使用人工泪液,劣质角膜染色分数> / = 0.5(0 - 4)规模,Schirmer撕裂试验(没有麻醉)> / = 1和/ = 40(0 - 100视觉模拟量表(血管))。方法:受试者随机1:1后14天安慰剂试车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:Co-primary疗效终点变化,从基线到第84天,眼睛干涩的得分(血管,两眼)伪劣角膜荧光素染色评分在指定的研究。次要终点变化,从基线到第84天,眼部不适的得分(0 - 4规模)研究眼睛,眼睛不适得分(血管),眼睛角膜染色总分在这项研究中,鼻结膜丽丝胺绿色染色评分(0 - 4规模)研究。治疗诱发不良事件(流泪)记录。结果:共有718名受试者随机:安慰剂,n = 360;lifitegrast n = 358 (intent-to-treat人口)。 Lifitegrast-treated subjects experienced greater improvement in eye dryness than placebo-treated subjects (treatment effect, 12.61; 95% confidence interval [CI], 8.51-16.70; P < 0.0001). There was no between-group difference in inferior corneal staining (treatment effect, 0.03; 95% CI, -0.10 to 0.17; P = 0.6186). There was nominally significant improvement of secondary symptom end points among lifitegrast-treated subjects: ocular discomfort (nominal P = 0.0005) and eye discomfort (nominal, P < 0.0001). There were no between-group differences on secondary signs: total corneal staining and nasal lissamine staining. More lifitegrast-treated subjects (33.7%) than placebo-treated subjects (16.4%) experienced ocular TEAEs; no ocular TEAEs were serious. CONCLUSIONS: Lifitegrast met the co-primary symptom end point (eye dryness) but not the co-primary sign end point (inferior corneal staining). Secondary end point findings were consistent with this pattern. Most ocular TEAEs were mild to moderate; there were no unexpected TEAEs. Lifitegrast warrants further consideration as a treatment for DED.

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Lifitegrast