NCT02284516已完成3 期
A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 711
- 试验地点
- 41
- 主要终点
- Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
研究概览
简要总结
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient-reported history of Dry Eye Disease in both eyes.
- •Use of over the counter artificial tears within the past 30 days.
- •A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
- •Able and willing to comply with all study procedures.
排除标准
- •Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
- •Unwilling to stop wearing contact lenses during the study.
- •LASIK or other ocular surgical procedures within 12 months prior to or during the study.
- •Use of prohibited medications
- •Significant medical conditions that could affect the study parameters.
研究组 & 干预措施
Lifitegrast
Experimental
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
干预措施: Lifitegrast (Drug)
Placebo
Placebo Comparator
Placebo to match active treatment, BID for 84 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
时间窗: Baseline to Day 84
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
次要结局
- Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42(Baseline to Day 14 and Day 42)
研究者
研究点 (41)
Loading locations...
相似试验
已完成
4 期
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens WearersDry EyeNCT05505292State University of New York College of Optometry32
已完成
3 期
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry EyeDry Eye DiseaseNCT01743729Shire720
已完成
3 期
Safety Study of Lifitegrast to Treat Dry EyeDry Eye DiseaseNCT01636206Shire332
已完成
4 期
Effect of Lifitegrast on Dry Eye Disease Signs and SymptomsDry EyeNCT03451396Lifelong Vision Foundation30
已完成
4 期
The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) StudyDry EyeNCT04669561Research Insight LLC100