jRCT2031250103招募中不适用
SJP-0049 Phase 2 -A Single-Center, Single-Masked, Randomized, Placebo-Controlled, Parallel-Group Comparative Study in Patients with Allergic Conjunctivitis-
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 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
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Aged 18 years or older at the time of Informed Consent (any gender)
- •Live in Japan
- •Have a history of allergic conjunctivitis.
- •Meet the other protocol-specified inclusion criteria
排除标准
- •Need to wear contact lens during the study
- •Have a history of ocular surgery during the period specified in protocol, or scheduled surgery during the study
- •Have a history of punctal occlusion during the period specified in protocol, or schedule during the study
- •Have participated in another clinical trial and received investigational drug during the period specified in protocol, or scheduled during the study
- •Have a use of prohibited concomitant medications during the period specified in protocol, or unable to discontinue using or anticipate using during the study
- •Have active ophthalmic disease other than allergic conjunctivitis
- •Have known history of hypersensitivity to any of the study drug ingredients -Pregnant, potentially pregnant, lactating or intending to become pregnant. Unable to obtain a consent to practice adequate contraception during the study -Unable to obtain a consent 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
-
Subjective ocular symptom score
次要结局
未报告次要终点
研究者
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