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临床试验/NCT01252121
NCT01252121已完成不适用

Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

Alcon Research0 个研究点目标入组 27 人开始时间: 2010年10月最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

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