Overview
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.
Eligibility
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