NCT01086943已完成1 期
Clinical Safety Study on an Eyelid Warming Device, Moist Heat Technology BLEPHASTEAM®, to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids.
Prospective, non comparative, open, monocentre study.
The objectives are:
- To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application
- To evaluate the ocular surface, NIBUT and IOP before and after device application
- To determine the acceptability of healthy volunteers on the practical use of this device
The subjects will attend 2 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged from 18 to 80 years old.
- •Healthy volunteers.
- •For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week)
- •Normal ocular examination in both eyes.
排除标准
- 未提供
研究者
研究点 (1)
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