NCT00988494已完成2 期
Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Restoration of corneal epithelial defect
研究概览
简要总结
Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has corneal epithelial defect and decreased corneal sensitivity.
- •Has undergone continuous treatment for corneal epithelial defect for 1 week or longer.
排除标准
- •Presence of disease such as active ocular infection, or abnormal lid closure.
- •History or presence of chemical burn, Stevens - Johnson Syndrome, etc.
- •History of corneal transplantation, LASIK, or hematopoietic stem cell transplantation.
研究组 & 干预措施
High concentration
Experimental
DE-105 high concentration
干预措施: DE-105 ophthalmic solution (Drug)
Low concentration
Experimental
DE-105 low concentration
干预措施: DE-105 ophthalmic solution (Drug)
Placebo
Placebo Comparator
DE-105 placebo
干预措施: Placebo ophthalmic solution (Drug)
结局指标
主要结局
Restoration of corneal epithelial defect
时间窗: Every week
次要结局
- Visual acuity,etc.(Exit visit,etc.)
研究者
研究点 (1)
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