NCT02917512已完成2 期
A Multicenter, Placebo Controlled, Restasis® Referenced, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/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
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- change from Baseline of Corneal staining score - Oxford grading
研究概览
简要总结
A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome
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
- 是
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
- •Volunteer who has negative result of pregnancy test or use effective contraception
排除标准
- •Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- •The patients with systemic or ocular disorders affected the test result
- •Being treated with systemic steroid
- •Wearing contact lenses within 3 days of screening visit
- •Pregnancy or Breastfeeding
研究组 & 干预措施
HU00701
Experimental
HU00701(Cyclosporine 0.01% + 3% trehalose)
1 drop b.i.d at 12 hour interval for 12 weeks
干预措施: HU00701 (Drug)
HU007
Experimental
HU007(Cyclosporine 0.02% + 3% trehalose)
1 drop b.i.d at 12 hour interval for 12 weeks
干预措施: HU007 (Drug)
Restasis
Active Comparator
Restasis(Cyclosporine 0.05%)
1 drop b.i.d at 12 hour interval for 12 weeks
干预措施: Restasis (Drug)
Placebo(without main component)
Placebo Comparator
Placebo
1 drop b.i.d at 12 hour interval for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
change from Baseline of Corneal staining score - Oxford grading
时间窗: Week 12
次要结局
- change from Baseline of Corneal staining score - Oxford grading(Week 4, 8)
- change from Baseline of Strip meniscometry assessment(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)
研究者
研究点 (1)
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