NCT05304637Unknown4 期
Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Schirmer score
研究概览
简要总结
iTEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed.
详细描述
TEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed. At both exam days, a Schirmer test before and after will be performed as well as parameters which indicate immediate effect of treatment and treatment over the 30 days.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •unable to read consent
- •investigator discretion
研究组 & 干预措施
Therapy Arm
Experimental
Patient receive iTEAR100 treatment
干预措施: iTEAR100 treatment (Device)
结局指标
主要结局
Schirmer score
时间窗: within 5 minutes of stimulation
Difference between Schirmer score measured before stimulation and after stimulation at each visit
次要结局
- Symptom Scores(30 days)
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)Focal Segmental Glomerulosclerosis (FSGS)NCT03448692Pfizer47
已完成
2 期
Ph2, Study to Assess the Safety and Efficacy of GPC 100 and Propranolol With and Without G-CSF for the Mobilization of Stem Cells in Patients With Multiple Myeloma Undergoing Autologous Stem Cell TransplantMultiple MyelomaNCT05561751GPCR Therapeutics, Inc.30
已完成
2 期
To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT00827996Florida Academic Dermatology Centers10
终止
2 期
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis SuppurativaChronic Urticaria, IdiopathicHidradenitisHidradenitis SuppurativaNCT06555328InflaRx GmbH73
撤回
2 期
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated LiposarcomaDedifferentiated LiposarcomaNCT00969917Infinity Pharmaceuticals, Inc.