Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 主要终点
- OSDI
研究概览
简要总结
This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves.
详细描述
Chronic inflammation is implicated in the majority of chronic dry eyes. The parasympathetic nervous system is responsible for both basal tear secretion (the aqueous layer) by the lacrimal functional unit, and is responsible for controlling many aspects of chronic inflammation via the vagus nerve.
This study will document its effects on dry eyes, in addition to other symptoms/signs of low parasympathetic nervous system functioning using an over-the-counter supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have dry eye (OSDI score 30 and above)
- •Tear break up time of less than or equal to 7 seconds
- •Must be able to come for baseline tests and again at 4 weeks
排除标准
- •Corneal scarring
- •must not take Physostigmine (glaucoma), Pyridostigmine (Mestinon), Neostigmine (for Myasthenia Gravis); Aricept (for Alzheimer's), or ingredients to NeuroTears
- •No known allergies to ingredients in NeuroTears
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Treatment with NeuroTears
干预措施: NeuroTears (Dietary Supplement)
结局指标
主要结局
OSDI
时间窗: 4 weeks
Ocular Surface Disease Index
次要结局
未报告次要终点