drugset / Trial / NCT05887336

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

NCT05887336

Completed 106 enrolled Abilion Medical Systems AB
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-06-01
Primary completion
2024-08-01
Completion
2024-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hyaluronic Acid Other / unclassified
Comparator Hyaluronic acid and Ectoin Unknown

Indications