A randomized, double blind, parallel group, active controlled, multicentric, phase III study comparing the efficacy, safety and tolerability of Lifitegrast 5% eye drops in patients with dry eye disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 11
- 主要终点
- The mean change in Eye dryness score
研究概览
简要总结
Dry eye disease is a significant health burden. This study is designed toassess the efficacy, safety and tolerability of Lifitegrast 5% eye drops versusCarboxymethylcellulose 0.5% eye drops in patients with dry eye disease. Themean changes in study variables from baseline to weeks 2, 6, and 12 within groupA and group B were statistically significant (p<0.001), suggesting thatsubjects in both groups showed significant improvement at all study visits. Thechanges were higher in group A as compared to group B, suggesting that subjectstreated with 5% lifitegrast showed greater improvement in signs and symptoms ofDED after 12 weeks of treatment compared to subjects treated with 0.5%carboxymethylcellulose
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects ≥18 years to 65 years of age both gender •Subjects with known case of dry eye disease •Subject on artificial tears for the past 30 days for DED •Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better •Normal lid position and closure.
- •â€¢In case of women, postmenopausal (>12 months without menstrual bleeding), •Surgically sterilized, or on use of effective birth control measures •Willingness to sign written informed consent document.
排除标准
- •â€¢Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •â€¢Any ocular condition that, in the opinion of the Investigator, could affect study parameters.
- •This include, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy or, any other condition as deemed by the Investigator.
- •â€¢Any significant illness that could interfere with study parameters •History of any other ocular surgical procedure within 12 months •Subject with known allergy or hypersensitivity to the components of the formulation •Participation in another clinical trial within past 30 days.
结局指标
主要结局
The mean change in Eye dryness score
时间窗: baseline, Week-2, Week-6 and Week-12
次要结局
- The mean change in the Schirmer Tear Test (without anesthesia)(The mean change in Subject rated global improvement scale)