Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Fluorescein Tear Clearance With Application
研究概览
简要总结
The objectives of this study are:
- To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
- To compare the goblet cell count following application between the intranasal and extranasal applications
- To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications
详细描述
In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:
- Active intranasal device application
- Active extranasal device application
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral dry eyes
- •Capable of providing written informed consent
排除标准
- •Chronic or recurring epistaxis (nosebleeds)
- •Blood coagulation disorder
- •Uncontrolled or poorly controlled diabetes
- •Heart or pulmonary disease
- •Females who are pregnant, planning a pregnancy or nursing
研究组 & 干预措施
Intranasal then Extranasal Application
Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
干预措施: Oculeve Intranasal Lacrimal Neurostimulator (Device)
Extranasal then Intranasal Application
Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
干预措施: Oculeve Intranasal Lacrimal Neurostimulator (Device)
结局指标
主要结局
Fluorescein Tear Clearance With Application
时间窗: Day 1
次要结局
未报告次要终点