NCT04250207已完成2 期
A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12 Week, Phase 2 Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Patients With Fuchs Endothelial Corneal Dystrophy
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
- 65
- 试验地点
- 29
- 主要终点
- Central Corneal Endothelial Cell Density (ECD) at Week 12
研究概览
简要总结
The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.
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
- •Is at least 18 years old at the screening visit (Visit 1).
- •Has a diagnosis of FECD at Visit
- •Meet all other inclusion criteria outlined in clinical study protocol.
排除标准
- •Has a study eye with a history of cataract surgery within 90 days of Visit
- •Has a study eye with a history of any previous ocular surgery other than for cataract.
- •Meet any other exclusion criteria outlined in clinical study protocol.
研究组 & 干预措施
K-321 QID
Experimental
K-321 Ophthalmic Solution Dose A
干预措施: K-321 Solution (Drug)
K-321 BID
Experimental
K-321 Ophthalmic Solution Dose B
干预措施: K-321 Solution (Drug)
K-321 BID
Experimental
K-321 Ophthalmic Solution Dose B
干预措施: Placebo Solution (Drug)
Placebo
Placebo Comparator
Vehicle Solution Dose
干预措施: Placebo Solution (Drug)
结局指标
主要结局
Central Corneal Endothelial Cell Density (ECD) at Week 12
时间窗: Baseline to Week 12
Change in Central ECD at week 12
次要结局
- Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit(Baseline to Week 52)
- Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness(Baseline up to Week 52)
- Central Corneal ECD From Baseline to Each Subsequent Visit(Baseline to Week 52)
- Change From Baseline in Central Corneal Thickness(Baseline to Week 52)
- Time to Achievement of no Corneal Oedema of Study Eye(Baseline to Week 52)
- Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit(Baseline to Week 52)
- Time to Achieve Central Corneal ECD 700 Cells/mm2 or More(Up to 52 Weeks)
- Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness(Baseline up to 52 Weeks)
- Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit(Baseline to Week 52)
研究者
研究点 (29)
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