jRCT2031220497已完成不适用
SJP-0132 Phase 3 - Multicenter, Randomized, Double-Masked, Placebo Controlled, Parallel-Group Study in Patients with Dry Eye Disease -
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 498
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Aged over 18 years at the time of the informed consent(any gender)
- •Live in Japan
- •Have continuous subjective symptoms of dry eye disease
- •Tear film break-up time of <= 5 seconds
- •Meet the other protocol-specified inclusion criteria may apply
排除标准
- •Unable to discontinue wearing contact lens during the study
- •Have a history of, or scheduled corneal transplantation during the study
- •Have a history of, or scheduled permanent punctal occlusion during the study
- •Have used or anticipates use of a punctal plug during the study - Have a history of, or scheduled ocular surface surgery during the study
- •Have ophthalmic disease other than dry eye disease - Have disease that affects subjective symptoms of dry eye - Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients - Unable to discontinue any ophthalmic medicines including OTC, except test drug for ophthalmic examination during the study - Female participant who is pregnant, potentially pregnant, lactating or intents to become pregnant. And unable to obtain a consent to practice adequate contraception during the study - Male participant who does not agree to practice adequate contraception and not to donate sperm during the study
- •Have judged that it is inappropriate to participate in this study by investigator
- •Meet the other protocol-specified exclusion criteria
结局指标
主要结局
-
Change from baseline in dry eye symptoms
次要结局
未报告次要终点
研究者
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