Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Tear Film Evaporation Rate
研究概览
简要总结
The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Mild or greater dry eye symptoms.
- •Evidence of evaporative dry eye
排除标准
- •Known allergy or sensitivity to the study product(s) or its components
- •Current contact lens wearer
- •Systemic or ocular allergies
- •Use of systemic medication which might have ocular side effects.
- •Any ocular infection.
- •Use of ocular medication.
结局指标
主要结局
Tear Film Evaporation Rate
时间窗: after 30 days of eyedrop usage
The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10\^-7 g/cm\^2 /s and recorded for relative humidity of 25% to 35%.
次要结局
- Tear Break Up Time(after 30 days of eyedrop usage)
- Ocular Surface Disease Index Score(after 30 days of eye drop usage)