Efficacy and Safety Study of Haporine-S in Subjects With Moderate to Severe Dry Eye, A Multicenter, Investigator(Assessor)Blind, Parallel Design, Non-inferiority Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Corneal staining
研究概览
简要总结
The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.
详细描述
This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.
Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 20 or over
- •Patients with moderate to severe dry eye(DEWS Level II or over)
- •Be informed of the nature of the study and will give written informed consent
排除标准
- •Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye
- •Being treated with systemic steroid or immunosuppressive
- •History of eyeball surgical operation within 6 months
- •Wearing contact lenses during participation of the study
- •Pregnancy or breastfeeding
- •Use of cyclosporine eye drop within 2 weeks
- •Intraocular pressure(IOP)> 25 mmHg
- •History of punctal occlusion within 1 month or during participation of the study
- •Hypersensitivity to the investigational products or be suspicious to them
- •Patients whom the investigator considers inappropriate to participate in the study
研究组 & 干预措施
Haporine-S
Moderate to severe dry patients administered with with Haporine-S
干预措施: Haporine-S (Drug)
Restasis, Cyclosporine 0.05%
Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)
干预措施: Restasis (cyclosporine 0.05%) (Drug)
结局指标
主要结局
Corneal staining
时间窗: up to 12 weeks
Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
次要结局
- Ocular Surface Disease Index(OSID)(0 day, 4 weeks and 12 weeks)
- Tear Breakup Time(TBUT)(0 day, 4 weeks and 12 weeks)
- Drug compliance(0 day, 4 weeks and 12 weeks)
- DEWS(Dry Eye WorkShop) level(0 day, 4 weeks and 12 weeks)
- Schirmer score(0 day, 4 weeks and 12 weeks)