NCT02979054已完成不适用
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 5
- 主要终点
- Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
研究概览
简要总结
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adult patients diagnosed with progressive keratoconus
- •Patients who signed and dated informed consent
排除标准
- •Patient under 18 years
- •History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
- •Corneal thickness< 400µm
研究组 & 干预措施
T4020
Experimental
1 drop every other day during 5 days
干预措施: T4020 (Device)
Saline solution
Placebo Comparator
1 drop every other day during 5 days
干预措施: Placebo (Device)
结局指标
主要结局
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
时间窗: Day 3
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
时间窗: Day 4
次要结局
- Number of Participants With Treatment-emergent Adverse Events(Through study completion, an average of 1 month)
- Corneal Epithelial Defect Size Assessment(Baseline and Day 5)
研究者
研究点 (5)
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