drugset / Trial / NCT05887336
Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hyaluronic Acid | Other / unclassified | — | — |
| Comparator | Hyaluronic acid and Ectoin | Unknown | — | — |