NCT01483989已完成不适用
In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
研究概览
简要总结
The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.
详细描述
The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have history of dry eye as determined by:
- •Questionnaire
- •Tear Film Break Up Time less than or equal to 10 seconds
- •Schirmer's score of less than or equal to 5 mm
- •Corneal staining greater than or equal to 3 in either eye, and
- •Positive for conjunctival staining (greater than or equal to 1)
排除标准
- •Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.
结局指标
主要结局
Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
时间窗: baseline and 28 days
The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
次要结局
未报告次要终点
研究者
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