Tear Film Innovations iLux Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
研究概览
简要总结
The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.
详细描述
Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.
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
- •Sign written informed consent prior to study participation
排除标准
- •History of ocular surgery within 1 year
- •Active ocular infection
- •Ocular surface abnormality; lid surface abnormalities
- •Pregnant, nursing or not utilizing adequate birth control measures
- •Other protocol-specified exclusion criteria may apply
结局指标
主要结局
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
时间窗: Day 0 immediately post-treatment
Post-heating values were obtained by infrared camera for each participant. The cornea, the eyelid, and the surface tissue surrounding the eye were measured. Both eyes contributed to the analysis. No formal hypothesis testing was specified.
次要结局
未报告次要终点