NCT04548427已完成3 期
Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-352 Eye Drops in Patients With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Changes in Corneal Staining from Baseline and at Week 4
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease
详细描述
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than the age of 19 years old
- •Subjects with dry eye symptoms for at least 3 month
- •Subjects who sign on an informed consent form willingly
排除标准
- •Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
- •Subjects who have clinically significant medical history of ocular disability
- •Subjects who have malignant tumor within 5 years
- •Subjects with known hypersensitivity to investigational product
- •Women who are nursing, pregnant or planning pregnancy during the study
- •Subjects who have received any other investigational product
- •Impossible subjects who participate in clinical trial by investigator's decision
研究组 & 干预措施
CKD-352
Experimental
干预措施: CKD-352 (Drug)
Diquafosol Sodium 3%
Active Comparator
干预措施: Diquafosol Sodium 3% (Drug)
结局指标
主要结局
Changes in Corneal Staining from Baseline and at Week 4
时间窗: Baseline, Week 4
次要结局
- Changes in Ocular Surface Disease Index from Baseline and at week 2, 4(Baseline, Week 2,4)
- Changes in Corneal Staining from Baseline and at Week 2(Baseline, Week 2)
- Changes in Conjunctival Staining from Baseline and at Week 2,4(Baseline, Week 2,4)
- Changes in Tear Break-up Time from Baseline and at Week 2, 4(Baseline, Week 2,4)
- Changes in Schirmer I Test from Baseline and at Week 2, 4(Baseline, Week 2,4)
研究者
研究点 (1)
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