MedTrace Logo

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

NCT05887336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-11-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Abilion Medical Systems AB

    lead INDUSTRY

Principal Investigators

  • Fredrik Källmark, PhD · Källmarkskliniken

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05887336 on ClinicalTrials.gov