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临床试验/NCT02322528
NCT02322528已完成不适用

Evaluation of Ocular Surface Inflammatory Mediators and Ocular Surface Metrology Effected by Lotemax

University of Rochester1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Ocular Surface Temperature of Both Eyes

研究概览

简要总结

The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Administration of Lotemax

Other

An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.

干预措施: Administration of Lotemax (Drug)

结局指标

主要结局

Ocular Surface Temperature of Both Eyes

时间窗: baseline, 30 minutes, week 1, week 2

Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.

Visual Quality

时间窗: baseline, 30 minutes, week 1, week 2

Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James V. Aquavella, MD

Principal Investigator

University of Rochester

研究点 (1)

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