NCT05887336

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Abilion Medical Systems AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye
• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	Walther System	Walther System providing INMEST treatment
DEVICE	Sham Walther System	Walther System not providing INMEST treatment, but otherwise behave as the active comparator.
DRUG	Non preserved ocular lubricants	* Hyaluronic acid (HyloGel) * Hyaluronic acid and Ectoin (Hylo Dual Intense) * Hyaluronic acid and Trehalos (Theloz Duo)
PROCEDURE	Eye lid procedure	Lid hygiene, warm eye bag, lid massage and Omega 3

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-08-01
• Completion: 2024-10-31
• First posted: 2023-06-02
• Last updated: 2024-11-05

Locations

3 sites across 2 countries: Denmark, Sweden