NCT01086774已完成4 期
Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Improvement in maximum blink interval (MBI)
研究概览
简要总结
Evaluation of the optical effects of Systane Ultra
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
- 是
入选标准
- •Age 18 years or more.
- •Subjects must have Tear Break Up Time (TBUT) < 5 seconds
- •Subjects must have a maximum blink interval (MBI) < 10 seconds
- •Subjects must be willing to comply with all study requirements.
- •Subjects must understand, sign and be given a copy of the written Informed Consent form.
排除标准
- •Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
- •Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
- •Subjects with known sensitivity to planned study concomitant medications
- •Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
- •Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication
结局指标
主要结局
Improvement in maximum blink interval (MBI)
时间窗: 1 day
次要结局
- Tear film stability and contrast sensitivity(1 day)
研究者
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