Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye - a Prospective, Double-blind, Pivotal Study to Evaluate the Safety and Performance of the Walther System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Change in Ocular Surface Disease Index (OSDI)
研究概览
简要总结
The purpose of the study is to investigate the degree of symptom relief in people with signs or symptoms of dry eyes after self-treatment at home with the Walther System delivering INMEST (intranasal mechanical stimulation).
A total of 110 subjects are planned to be enrolled and randomized to either use an active device or a sham device. Both groups will also receive standard treatment in mainstream healthcare for symptoms of dry eye. The subject self-administer treatments at home, three times a week for six weeks, with a follow-up period of three months after end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
- •History of dry eye in both or one eye, supported by a previous clinical diagnosis or have self-reported history of complaints for at least 4 months prior to enrolment
- •Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study
- •OSDI score > 15
- •Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds
- •Anticipated compliance with prescribed treatment and follow-up
排除标准
- •Recently (3 months prior enrolment) undergone nasal or sinus surgery
- •Women who are pregnant as determined by urine test at inclusion and prior to study start (applies to sites in Denmark only)
- •Ongoing acute upper respiratory tract infection, per the Investigator's judgement
- •Bleph-ex treated within 3 months prior to enrolment
- •The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
- •The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
- •Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
- •Previous (within 30 days prior to enrolment/randomization) and concurrent treatment during the treatment phase with another investigational drug/s or device/s
研究组 & 干预措施
Investigational device treament and standard treatment
After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.
干预措施: Walther System (Device)
Investigational device treament and standard treatment
After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.
干预措施: Non preserved ocular lubricants (Drug)
Investigational device treament and standard treatment
After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.
干预措施: Eye lid procedure (Procedure)
Sham device treatment and standard treatment
After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.
干预措施: Sham Walther System (Device)
Sham device treatment and standard treatment
After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.
干预措施: Non preserved ocular lubricants (Drug)
Sham device treatment and standard treatment
After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.
干预措施: Eye lid procedure (Procedure)
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI)
时间窗: Treatment period, up to 6 weeks
Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.
次要结局
- Schirmer's Test(Follow-up period, up to 3 months)
- Lipid Layer Test(Follow-up period, up to 3 months)
- Non-Invasive Tear Break-Up time (NIBUT)(Follow-up period, up to 3 months)
- Tear Meniscus Height (TMH)(Follow-up period, up to 3 months)
- Adverse Events(Study period, up to 4.5 months)
- Device Deficiencies(Treatment period, up to 6 weeks)
- Remission(Treatment period, up to 6 weeks)
- Corneal Staining Test(Follow-up period, up to 3 months)
- Compliance(Study period, up to 4.5 months)
- Lissamine Green Test(Follow-up period, up to 3 months)