Prospective Controlled Study of Intranasal Tear Neurostimulation for Sjogrens Patients With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Schirmer Testing
研究概览
简要总结
The purpose of this study is to evaluate acute tear production produced by the intranasal tear neurostimulator in participants with Sjögrens syndrome and aqueous tear deficiency. Our primary goal is to evaluate whether Sjögrens patients respond to this intervention and whether there is a baseline tear production level below which these patients do not respond.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Subjects with Sjögren's syndrome based on American-European Consensus Group (AECG) American College of Rheumatology (ACR), or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria
- •Baseline Schirmer score (with topical anesthesia) of ≤10 mm/5 min and retest value (during nasal stimulation with cotton swab) of at least 4 mm/5min higher than baseline value
- •Baseline Ocular Surface Disease Index® (OSDI) total score ≥13
- •Age greater than or equal to 22 years old
- •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
- •Use of any topical ophthalmic medication, including artificial tears, within 4 hours of either visit
- •Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
- •Use of systemic anticoagulants
- •Nasal or sinus surgery including nasal cautery or significant trauma
- •Severely deviated septum
- •Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
- •Have an active implanted metallic or active implanted electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
- •Known hypersensitivity to any of the procedural agents or materials in the study device that contact the nasal mucosa
- •Corneal transplant in either or both eyes
- •Participation in any clinical trial within 30 days of the Screening Visit
- •A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
结局指标
主要结局
Schirmer Testing
时间窗: Immediately following the procedure (ie immediately following use of the device)
Tear production measured immediately following intranasal tear neurostimulation. For this measurement, Schirmer strips (small strips of paper with measurements on them) are placed in the corner of each eye. The amount of wetting of the Schirmer strips is measured in millimeters. Wetting of less than 5 mm is indicative of deficient tear production.
次要结局
- Clinically Significant Changes in Visual Acuity(Immediately following the procedure (ie immediately following use of the device))
- Clinically Significant Changes in Slit Lamp Exam(Immediately following the procedure (ie immediately following use of the device))
- Number of Adverse Events(Immediately following the procedure (ie immediately following use of the device))