Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye

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

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.

Inclusion Criteria:

1. Age ≥ 18
2. The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
3. 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
4. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study
5. OSDI score > 15
6. Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds
7. Anticipated compliance with prescribed treatment and follow-up

Exclusion Criteria:

1. Recently (3 months prior enrolment) undergone nasal or sinus surgery
2. Women who are pregnant as determined by urine test at inclusion and prior to study start (applies to sites in Denmark only)
3. Ongoing acute upper respiratory tract infection, per the Investigator's judgement
4. Bleph-ex treated within 3 months prior to enrolment
5. The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
6. The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
7. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
8. Previous (within 30 days prior to enrolment/randomization) and concurrent treatment during the treatment phase with another investigational drug/s or device/s