NCT01335126Unknown3 期
Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
Hom, Milton M., OD, FAAO0 个研究点目标入组 48 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 48
- 主要终点
- Tolerability Questionnaire
研究概览
简要总结
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and over inclusive.
- •Males or females
- •Patient is in generally good & stable overall health.
- •Patient likely to comply with study guidelines & study visits.
- •Informed consent signed.
- •OSDI score >18 OR
- •TBUT <10 seconds
排除标准
- •Corneal refractive surgery or contact lens wear within 6 months of this study.
- •Current use of Restasis
- •Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- •Pregnant or lactating women.
- •Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
结局指标
主要结局
Tolerability Questionnaire
时间窗: 8 weeks
Tolerability (comfort) measured with Visual Analog scale (1 to 100)
次要结局
- Acceptability Questionnaire(8 weeks)
- Tear Break Up Time(2-3 weeks)
研究者
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