Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Difference in Ratio of Degranulated Goblet Cells.
研究概览
简要总结
The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- •Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study
- •The participant should be literate, able to speak English, and able to complete questionnaires independently
排除标准
- •Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
- •Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- •Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
- •Corneal transplant in either or both eyes
- •Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
- •Women who are pregnant, planning a pregnancy, or nursing throughout the study
研究组 & 干预措施
ITN [TrueTear®] - Intranasal Application
Intranasal application of the ITN. Single application at application visit.
干预措施: Intranasal Tear Neurostimulator (ITN) [TrueTear®] (Device)
ITN [TrueTear®] - Extranasal Application
Extranasal application of the ITN. Single application at application visit.
干预措施: Intranasal Tear Neurostimulator (ITN) [TrueTear®] (Device)
结局指标
主要结局
Difference in Ratio of Degranulated Goblet Cells.
时间窗: Screening (Day -60 to Day -30) to Application Visit (Day 0)
Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit
次要结局
未报告次要终点