Lifitegrast Ophthalmic Solution 5.0% for Treatment of Dry Eye Disease: Overview of Clinical Trial Program

Clara C Chan; C. Lisa Prokopich

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Lifitegrast Ophthalmic Solution 5.0% for Treatment of Dry Eye Disease: Overview of Clinical Trial Program

机译：5.0％Lifitegrast眼药水用于治疗干眼症：临床试验计划概述

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Abstract Dry eye disease (DED) is a common inflammatory disorder of the ocular surface. Millions of people are affected by DED worldwide. Lifitegrast is a novel drug designed to inhibit DED-associated ocular inflammation. Four clinical trials have shown that lifitegrast is well tolerated and effective in improving symptoms and signs of DED over 12 weeks. A fifth trial showed long-term safety over 1 year. Lifitegrast has been in clinical use for more than one year in the United States and was recently approved in Canada (in December 2017). In this review, we discuss lifitegrast’s novel mechanism of action and provide an overview of its clinical trial program.

机译：摘要干眼病（DED）是一种常见的眼表炎性疾病。全球有数百万人受到DED的影响。 Lifitegrast是一种新型药物，旨在抑制DED相关的眼部炎症。四个临床试验表明，lifitegrast具有良好的耐受性，可在12周内有效改善DED的症状和体征。第五项试验显示一年以上的长期安全性。 Lifitegrast在美国已临床使用超过一年，最近在加拿大获得批准（2017年12月）。在这篇评论中，我们讨论了lifitegrast的新型作用机理，并概述了其临床试验计划。

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《Journal of Pharmacy and Pharmaceutical Sciences》 |2019年第1期|共8页
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Clara C Chan; C. Lisa Prokopich;
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1. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: combined evidence from 5 randomized controlled trials. [J] . Shojaei Amir, Darvish-Zargar Mahshad, Holland Edward J., Investigative ophthalmology & visual science . 2017,第8期

机译：LifiteGrast眼科溶液5.0％用于治疗干眼症：来自5项随机对照试验的组合证据。
2. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: combined evidence from 5 randomized controlled trials. [J] . Shojaei Amir, Darvish-Zargar Mahshad, Holland Edward J., Investigative ophthalmology & visual science . 2017,第8期

机译：LifiteGrast眼科溶液5.0％用于治疗干眼症：来自5项随机对照试验的组合证据。
3. Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease [J] . Nichols Kelly K., Donnenfeld Eric D., Karpecki Paul M., European journal of ophthalmology . 2019,第4期

机译：寿命推翻的安全性和耐受性，眼科溶液5.0％：干眼症五种随机对照试验的合并分析
4. HL036337 Ophthalmic Solution: Topical TNF Blocker for Dry Eye Disease [C] . Minjae Shin PEGS . 2015

机译：HL036337眼科溶液：用于干眼症的局部TNF阻滞剂
5. Development and evaluation of a novel porcine desiccation-induced dry eye model for investigation of the aetiology and treatment for dry eye: Implications for the ageing eye. [D] . Choy, Emily Pik Yin. 2006

机译：新型猪干燥引起的干眼模型的开发和评估，用于干眼病的病因和治疗研究：对衰老眼的影响。
6. Safety of Lifitegrast Ophthalmic Solution 5.0 in Patients With Dry Eye Disease: A 1-Year Multicenter Randomized Placebo-Controlled Study [O] . Eric D. Donnenfeld, Paul M. Karpecki, Parag A. Majmudar, -1

机译：Lifitegrast眼用溶液5.0％对干眼症患者的安全性：为期1年的多中心随机安慰剂对照研究
7. Safety and tolerability of lifitegrast ophthalmic solution 5.0: Pooled analysis of five randomized controlled trials in dry eye disease [O] . Kelly K Nichols, Eric D Donnenfeld, Paul M Karpecki, 2018

机译：寿命拉伸眼科溶液的安全性和耐受性5.0％：干眼症五种随机对照试验的合并分析
8. Clinical Trials Supported by the National Eye Institute: Evaluating New Approaches to the Treatment of Eye and Vision Disorders [R] . 1990

机译：国家眼科研究所支持的临床试验：评估治疗眼睛和视力障碍的新方法

Lifitegrast Ophthalmic Solution 5.0% for Treatment of Dry Eye Disease: Overview of Clinical Trial Program

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