NCT01239069已完成2 期
A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease
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
- Santen Inc.
- 入组人数
- 140
- 主要终点
- Efficacy of DE-110
研究概览
简要总结
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of 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
- Single (Investigator)
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
- •Confirmed diagnosis of dry eye
- •Not wear contact lenses during study
- •18 years or older
- •Understand and provide written consent
- •Negative pregnancy test and use acceptable method of contraception
排除标准
- •Use of any topical ocular medication
- •Any type of ocular surgery
- •Diagnosis of on-going ocular infection and/or allergic conjunctivitis
- •Uncontrolled systemic conditions/lid abnormalities
- •Corneal transplants
- •Females who are pregnant, nursing or planning a pregnancy
- •Participation in another drug trial concurrently or within 30 days prior to study
研究组 & 干预措施
DE-110 ophthalmic suspension high dose
Experimental
干预措施: DE-110 ophthalmic suspension high dose (Drug)
DE-110 ophthalmic suspension low dose
Experimental
干预措施: DE-110 ophthalmic suspension low dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy of DE-110
时间窗: 12 weeks
次要结局
- Individual Response Rate(12 weeks)
- Individual Efficacy(12 weeks)
- Individual Symptoms(12 weeks)
研究者
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