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
Overview
- Phase
- N/A
- Intervention
- Walther System
- Conditions
- Dry Eye
- Sponsor
- Abilion Medical Systems AB
- Enrollment
- 106
- Locations
- 3
- Primary Endpoint
- Change in Ocular Surface Disease Index (OSDI)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Walther System
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.
Intervention: Non preserved ocular lubricants
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.
Intervention: Eye lid 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.
Intervention: Sham Walther System
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.
Intervention: Non preserved ocular lubricants
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.
Intervention: Eye lid procedure
Outcomes
Primary Outcomes
Change in Ocular Surface Disease Index (OSDI)
Time Frame: Treatment period, up to 6 weeks
Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.
Secondary Outcomes
- 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)