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

Dry Eye Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05887336
Study type Interventional
Source Abilion Medical Systems AB
Contact Karl-Johan Pantzar
Phone +46739808065
Email kj@abilion.com
Status Recruiting
Phase N/A
Start date June 2023
Completion date June 2024
View Details
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