A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Tear Meniscus Height Captured by Optical Coherence Tomography
研究概览
简要总结
The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.
详细描述
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subjects with dry eye disease
- •Literate, able to speak English or Spanish, and able to complete questionnaires independently
- •Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
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
- •Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
- •Corneal transplant in either or both eyes
- •Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
- •Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit
研究组 & 干预措施
Active - Device
The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.
干预措施: Oculeve Intranasal Neurostimulator (Device)
结局指标
主要结局
Tear Meniscus Height Captured by Optical Coherence Tomography
时间窗: Day 1
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
次要结局
未报告次要终点