NCT01252121已完成不适用
Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Ocular surface residence time
研究概览
简要总结
The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.
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
- Double (Participant, 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
- 否
入选标准
- •Diagnosed with mild to moderate dry eye as defined in the protocol.
- •Able and willing to follow instructions.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any medical condition that may affect the results of the study.
- •History or evidence of ocular or intraocular surgery within the past six months.
- •History of intolerance or hypersensitivity to any component of the study medications.
- •Use of concomitant topical ocular medications during the study period.
- •Ocular conditions that may preclude safe administration of the test article.
- •Unwilling to discontinue contact lens wear during the study period.
- •Participation in an investigational drug or device study within 30 days of enrollment.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Ocular surface residence time
时间窗: Time to event
Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.
次要结局
未报告次要终点
研究者
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