NCT02092207已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase II Clinical Study to Evaluate the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
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
- 147
- 试验地点
- 9
- 主要终点
- Change in corneal staining score
研究概览
简要总结
This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Corneal staining score of ≥5 in either eye by the National Eye Institute/Industry Workshop guidelines
- •Schirmer test score (without anesthesia) < 7 mm/5 min in either eye
- •Willing to use no topical ocular treatments, other than REFRESH TEARS® for the duration of the trial
排除标准
- •Intraocular surgery within 3months
- •Persistent intraocular inflammation or infection
- •Corneal transplantation or neurotrophic keratitis
- •Stevens-Johnson Syndrome
- •Ocular herpes simplex virus infection
- •Concomitant use of contact lenses or use within 3months
- •Silicone lacrimal punctal occlusion or cauterization of the punctum within 3months
- •Vision correction surgery without DES within 12months
- •Unstable use of methotrexate or Disease-modifying drugs
研究组 & 干预措施
KL7016 900mg
Experimental
干预措施: KL7016 900mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
KL7016 600mg
Experimental
干预措施: KL7016 600mg (Drug)
结局指标
主要结局
Change in corneal staining score
时间窗: baseline, 12 weeks
次要结局
- Change in schirmer test score(baseline, 4weeks, 8weeks, 12 weeks)
- Change in OSDI(Ocular Surface Disease Index)(baseline, 4weeks, 8weeks, 12 weeks)
- Change in TFBUT(Tear Film Break-up Time)(baseline, 4weeks, 8weeks, 12 weeks)
- Change in conjunctival staining score(baseline, 4weeks, 8weeks, 12 weeks)
- Change in corneal staining score(baseline, 4weeks, 8weeks)
研究者
研究点 (9)
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