NCT03461575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
- 209
- 试验地点
- 1
- 主要终点
- change from Baseline in Corneal staining(Oxford grading) 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
- •age over 19
- •Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min)
- •Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception
排除标准
- •The patients with systemic or ocular disorders affected the test result
- •Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- •Being treated with systemic steroid
- •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 (Drug)
结局指标
主要结局
change from Baseline in Corneal staining(Oxford grading) score
时间窗: Week 12
次要结局
- change from Baseline in Corneal staining(Oxford grading) score(Week 4,8)
- change from Baseline of Conjunctival staining(Oxford grading) score(Week 4,8,12)
- change from Baseline of Tear film break-up time(Week 4,8,12)
- change from Baseline of Standard patient evaluation of eye dryness questionnaire(Week 4,8,12)
- arrival time of 100% clearence in Corneal staining test(Week 0-12)
- The number of total rescue drug usage(Week 0-12)
- change from Baseline of Strip meniscometry assessment(Week 4,8,12)
研究者
研究点 (1)
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