NCT02503189已完成3 期
A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 主要终点
- Score of the corneal staining
研究概览
简要总结
The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dry eye patients with Sjögren's syndrome
- •Corneal and conjunctival damage
排除标准
- •Severe ophthalmic disorder
- •Punctal plugs or surgery for occlusion of the lacrimal puncta
研究组 & 干预措施
KCT-0809
Experimental
干预措施: KCT-0809 ophthalmic solution (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Score of the corneal staining
时间窗: 12 weeks
次要结局
- Score of the conjunctival staining(12 weeks)
研究者
相似试验
已完成
2 期
A Phase II Study of KCT-0809 in Patients With Dry Eye SyndromeDry Eye SyndromesNCT01427816Kissei Pharmaceutical Co., Ltd.180
终止
3 期
An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's SyndromeDry Eye With Sjögren's SyndromeNCT02503176Kissei Pharmaceutical Co., Ltd.
已完成
3 期
A Long-term Study of KCT-0809 in Dry Eye Patients With Sjögren's SyndromeDry Eye With Sjögren's SyndromeNCT02503163Kissei Pharmaceutical Co., Ltd.
已完成
2 期
A Late Phase II Study of KCT-0809 in Patients With Dry Eye SyndromesDry Eye SyndromesNCT01890941Kissei Pharmaceutical Co., Ltd.
已完成
2 期
A Study of KCT-0809 in Patients With Dry Eye SyndromesDry Eye SyndromesNCT01211951Kissei Pharmaceutical Co., Ltd.160