Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 6
- 主要终点
- Stimulated Acute Tear Production
研究概览
简要总结
In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.
详细描述
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.
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 moderate to severe 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
- •Diagnosis of epilepsy
- •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
结局指标
主要结局
Stimulated Acute Tear Production
时间窗: The stimulated and prestimulation (basal) measures were both performed at Day 180.
Stimulated acute tear production in the study eye at Day 180 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm.
次要结局
- Corrected Distance Visual Acuity(Baseline and 6 months)
- Slit Lamp Biomicroscopy(6 months)