Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment Method for the Relief of Symptoms of Dry Eye
Dry Eye, Dry Eye Syndromes
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 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
Sites / Locations
- Øjenhospitalet Danmark
- Kontaktlinse Instituttet
- KällmarksklinikenRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Investigational device treament and standard treatment
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.
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.