JPRN-jRCT2031220497进行中（未招募）3 期
SJP-0132 Phase 3 - Multicenter, Randomized, Double-Masked, Placebo Controlled, Parallel-Group Study in Patients with Dry Eye Disease
Omatsu Kazunori0 个研究点目标入组 498 人开始时间: 2022年12月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 498
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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
研究者
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