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

Last updated: November 4, 2024
Sponsor: Abilion Medical Systems AB
Overall Status: Completed

Phase

N/A

Condition

Dry Eye Disease

Sjogren's Syndrome

Eyelid Inflammation

Treatment

Eye lid procedure

Walther System

Non preserved ocular lubricants

Clinical Study ID

NCT05887336
A-DE-002
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18

  2. The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments

  3. History of dry eye in both or one eye, supported by a previous clinical diagnosis orhave self-reported history of complaints for at least 4 months prior to enrolment

  4. Women of childbearing potential must agree to use a reliable, medically approvedform of contraception during the study participation until end of study

  5. OSDI score > 15

  6. Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds

  7. Anticipated compliance with prescribed treatment and follow-up

Exclusion

Exclusion Criteria:

  1. Recently (3 months prior enrolment) undergone nasal or sinus surgery

  2. Women who are pregnant as determined by urine test at inclusion and prior to studystart (applies to sites in Denmark only)

  3. Ongoing acute upper respiratory tract infection, per the Investigator's judgement

  4. Bleph-ex treated within 3 months prior to enrolment

  5. The study subject has a cognitive incapacity or language barrier precluding adequateunderstanding or cooperation

  6. The study subject is considered by the Investigator to be unsuitable to participatein the investigation for any other reason

  7. Any severe diseases interfering with the performance, evaluation, and outcome of theclinical evaluation

  8. Previous (within 30 days prior to enrolment/randomization) and concurrent treatmentduring the treatment phase with another investigational drug/s or device/s

Study Design

Total Participants: 106
Treatment Group(s): 4
Primary Treatment: Eye lid procedure
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Øjenhospitalet Danmark

    Charlottenlund, Copenhagen 2920
    Denmark

    Site Not Available

  • Kontaktlinse Instituttet

    Århus,
    Denmark

    Site Not Available

  • Källmarkskliniken

    Solna, Stockholm 171 54
    Sweden

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.