NCT02492412已完成3 期
Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects 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
- 101
- 主要终点
- Corneal staining Test to assess eye dryness
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.
详细描述
This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Corneal staining score of ≥2(Oxford grade)
- •Schirmer test score (without anesthesia) < 10 mm/5 min in either eye
- •Tear break-up time is 10 seconds or less
- •Screening both eyes, the corrected visual acuity is 0.2 or more
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
- •History of eyeball surgical operation within 3 months of screening visit
- •Wearing contact lenses within 2 weeks of screening visit
- •Be a use or used punctual plug within 1 month of screening vist
- •Use of cyclosporine eye drop within 3 weeks
- •Pregnancy or Breastfeeding
- •Intraocular pressure > 25 mmHg
- •Abnormal eyelid function : Disorders of the eyelids or eyelashes
研究组 & 干预措施
HE10
Experimental
Drug: HE10 1~2 drops b.i.d at 12 hour interval for 12 weeks
干预措施: HE 10 (Drug)
Restasis
Active Comparator
Drug: Restasis(Cyclosporine 0.05%) 1~2 drops b.i.d at 12 hour interval for 12 weeks
干预措施: Restasis (Drug)
结局指标
主要结局
Corneal staining Test to assess eye dryness
时间窗: 12 weeks
Change from baseline in eye dryness at 12 weeks
次要结局
未报告次要终点
研究者
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