CTRI/2021/10/037204已完成3 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
- •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
- •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.
- •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.
- •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
研究者
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