NCT05743764已完成3 期
A Multicenter, Randomized, Double Blind, Restasis®-Controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye 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
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Change from baseline in corneal staining score
研究概览
简要总结
A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 未提供
排除标准
- •The patients with clinically significant ocular disorders affected the test result
- •Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- •SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c>9%
- •Wearing contact lenses within 72 hr of screening visit
- •Pregnancy or Breastfeeding
研究组 & 干预措施
HU007
Experimental
Cyclosporine 0.02%, trehalose 3%
1 drop b.i.d at 12hr interval for 12 weeks
干预措施: HU007 (Drug)
Restasis
Active Comparator
Cyclosporine 0.05%
1 drop b.i.d at 12hr interval for 12 weeks
干预措施: Restasis (Drug)
Moisview
Active Comparator
trehalose 3%
1 drop b.i.d at 12hr interval for 12 weeks
干预措施: Moisview Eye drop (Drug)
结局指标
主要结局
Change from baseline in corneal staining score
时间窗: 12weeks
Change in corneal staining score assessed on Oxford grading at 12 weeks compared to baseline - Oxford grading: 0(Absent) to 5(Severe)
次要结局
- Change from baseline in corneal staining score(4, 8weeks)
- Change from baseline in conjuctival staining score(4, 8, 12weeks)
- Change from baseline in strip meniscometry score(4, 8, 12weeks)
- Change from baseline in TBUT score(4, 8, 12weeks)
- Change from baseline in SPEED dry eye questionnaire score(4, 8, 12weeks)
- Time to achieve 100% clearance in corneal staining(12weeks)
研究者
研究点 (1)
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