Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Tear Film Quality
研究概览
简要总结
Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye symptoms. Treatments often involve gently warming the eyelids to melt this blockage which prevents tears from spreading over the eye. Although there has been some research on application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and more effective method of applying heat to the eyelids. This study will test the efficiency of these eyelid warming devices over a period of two weeks use in one eye compared to the other non-treated eye.
详细描述
Study Design
Contralateral treatment study Randomised eye treated with heated eyebag in the morning and evening each day as per manufacturer's instructions Other eye acts as control with room temperature eyebag overlaid in same manner as treatment eye Investigators masked SMS messaging twice a day for 14 days to remind patients to use eyebag and collect 0-10 comfort score
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •18 or over
- •Have otherwise healthy eyes
- •Are prepared not to wear contact lens for the 2 weeks of the trial
- •Have a NITBUT <10s
- •OSDI score: greater than or equal to 12
- •Symptom frequency at least "some of the time"
- •Presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid AND/OR presence of poor expressibility from at least 2-3 of the central 8 glands on the lower lid
排除标准
- •Blepharitis
结局指标
主要结局
Change in Tear Film Quality
时间窗: Between baseline and 2 weeks
Non-invasive tear break up time: 3 measurements per eye
Change in Ocular Symptoms
时间窗: Between baseline and 2 weeks
Ocular symptomology: Ocular Surface Disease Index for right and left eyes
次要结局
- Change in Lipid layer thickness(Between baseline and 2 weeks)
- Change in Ocular redness(Between baseline and 2 weeks)
- Change in Meibomian Glands(Between baseline and 2 weeks)