NCT01057147已完成2 期
A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)
Kubota Vision Inc.19 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 19
- 主要终点
- Central corneal clearing as measured by fluorescein staining
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.
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
- •Age 18 years and older
- •Diagnosis of dry eye as defined by the protocol
- •Central corneal staining
排除标准
- •Ongoing ocular disease that may interfere with study parameters
- •Inability to stop using topical ophthalmic medications throughout the duration of the study
- •Inability to stop the use of contact lenses for the duration of the study
研究组 & 干预措施
rebamipide 2% ophthalmic suspension
Experimental
干预措施: rebamipide 2% ophthalmic suspension (Drug)
placebo eye drops
Placebo Comparator
干预措施: placebo eye drops (Drug)
结局指标
主要结局
Central corneal clearing as measured by fluorescein staining
时间窗: 12 weeks
次要结局
- Ocular staining(12 weeks)
- Dry eye symptoms(12 weeks)
研究者
研究点 (19)
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