Phase I, Prospective, Comparative Study, Investigator Masked , Monocentric Measuring Warming Efficiency and Safety of Blephasteam® Versus Warm Compresses in Eyelid Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Temperature measurements
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
Phase I, prospective, comparative study, investigator masked , monocentric
Objectives are To assess and compare the warming and moisture of Blephasteam® device versus the warming and moisture of warm and moist compresses.
To assess and compare safety on the ocular surface after 10 minutes of Blephasteam® application versus after 10 minutes of warm and moist compresses application
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
- Single (Investigator)
入排标准
- 年龄范围
- 4 Years 至 —（Child, 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
研究组 & 干预措施
Blephasteam Arm
干预措施: Warming goggles (Device)
warm and moist compresses arm
干预措施: warm and moist compresses (Device)
结局指标
主要结局
Temperature measurements
The temperature in the chamber of the goggles for Blephasteam device, or between the lid and the compresses for the moist and warm compress, will be evaluated in 10 consecutive measurements over a period of 10 minutes with a micro sensor at the lower lid margin of one randomly selected eye of 10 randomly selected subjects
次要结局
- Humidity measurements