NCT01632137已完成3 期
A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
Kubota Vision Inc.0 个研究点目标入组 564 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 564
- 主要终点
- Primary ocular sign: Fluorescein corneal staining total score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of dry eye-related ocular symptoms for at least 20 months.
- •Meet protocol-defined criteria for corneal and conjunctival staining.
- •Meet protocol-defined criteria for ocular discomfort.
排除标准
- •Active anterior segment ocular disease other than dry eye syndrome.
- •Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
- •Inability to suspend the use of contact lenses for the duration of the study.
- •Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
- •Received any other investigational product within 4 months before the screening visit.
研究组 & 干预措施
Placebo (vehicle)
Placebo Comparator
干预措施: Placebo (vehicle) (Drug)
Rebamipide 2% ophthalmic suspension
Experimental
干预措施: Rebamipide 2% ophthalmic suspension (Drug)
结局指标
主要结局
Primary ocular sign: Fluorescein corneal staining total score
时间窗: 4 weeks
Primary ocular symptom: Worst ocular symptom severity score
时间窗: 4 weeks
次要结局
- Fluorescein corneal staining total score(2 weeks)
- Worst ocular symptom severity score(2 weeks)
研究者
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