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Completed

NCT Number: NCT05887336

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Øjenhospitalet Danmark, Charlottenlund, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
  • History of dry eye in both or one eye, supported by a previous clinical diagnosis or have self-reported history of complaints for at least 4 months prior to enrolment
  • Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study
  • OSDI score > 15
  • Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds
  • Anticipated compliance with prescribed treatment and follow-up

Exclusion criteria

  • Recently (3 months prior enrolment) undergone nasal or sinus surgery
  • Women who are pregnant as determined by urine test at inclusion and prior to study start (applies to sites in Denmark only)
  • Ongoing acute upper respiratory tract infection, per the Investigator's judgement
  • Bleph-ex treated within 3 months prior to enrolment
  • The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
  • The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
  • Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
  • Previous (within 30 days prior to enrolment/randomization) and concurrent treatment during the treatment phase with another investigational drug/s or device/s

Treatment and study plan

Walther System

Device

Walther System providing INMEST treatment

Sham Walther System

Device

Walther System not providing INMEST treatment, but otherwise behave as the active comparator.

Non preserved ocular lubricants

Drug
  • Hyaluronic acid (HyloGel)
  • Hyaluronic acid and Ectoin (Hylo Dual Intense)
  • Hyaluronic acid and Trehalos (Theloz Duo)

Eye lid procedure

Procedure

Lid hygiene, warm eye bag, lid massage and Omega 3

Primary outcomes

  1. Change in Ocular Surface Disease Index (OSDI)

    Time frame: Treatment period, up to 6 weeks

    Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.

Secondary outcomes

  1. Adverse Events

    Time frame: Study period, up to 4.5 months

    Number of treatment related Adverse Events/Adverse Device Effects/Serious Adverse Events/Serious Adverse Device Effects and Unanticipated Serious Adverse Device Effects when using the Walther System.

  2. Device Deficiencies

    Time frame: Treatment period, up to 6 weeks

    Number of Walther System Device Deficiencies.

  3. Remission

    Time frame: Treatment period, up to 6 weeks

    Remission of estimated symptoms with OSDI after a treatment period of 6 weeks evaluated as a binary endpoint.

  4. Non-Invasive Tear Break-Up time (NIBUT)

    Time frame: Treatment period, up to 6 weeks

    Degree of increased Non-Invasive tear Break-Up time. Baseline result compared to result measured during treatment period.

  5. Schirmer's Test

    Time frame: Treatment period, up to 6 weeks

    Degree of improvement of tear production according to Schirmer's test. Baseline result compared to result measured during treatment period.

  6. Tear Meniscus Height (TMH)

    Time frame: Treatment period, up to 6 weeks

    Degree of change in TMH value. Baseline value compared to value measured during treatment period.

  7. Lissamine Green Test

    Time frame: Treatment period, up to 6 weeks

    Lissamine green test scale changes. Baseline scale compared with scale measured during treatment period.

  8. Corneal Staining Test

    Time frame: Treatment period, up to 6 weeks

    Corneal Staining test scale changes. Baseline scale compared with scale measured during treatment period.

  9. Lipid Layer Test

    Time frame: Treatment period, up to 6 weeks

    Degree of improvement of Lipid Layer coverage and thickness. Baseline result compared to results measured during the treatment period.

    The test is performed with a specific interference camera that visualizes the pre corneal lipid layer spread. The Interference colour chart allows quantification of the interference images, which are graded corresponding to lipid layer thickness and coverage. Images are classified from 5 grades; 1. Open meshwork, 2. Open to closed meshwork, 3. Closed to open meshwork, 4 Closed meshwork, 5. Colour fringe

  10. Non-Invasive Tear Break-Up time (NIBUT)

    Time frame: Follow-up period, up to 1 month

    Degree of increased Non-Invasive tear Break-Up time evaluated at 1 month after end of treatment period.

  11. Non-Invasive Tear Break-Up time (NIBUT)

    Time frame: Follow-up period, up to 3 months

    Degree of increased Non-Invasive tear Break-Up time evaluated at 3 months after end of treatment period.

  12. Schirmer's Test

    Time frame: Follow-up period, up to 1 month

    Degree of improvement of tear production according to Schirmer's test evaluated at 1 month after end of treatment period.

  13. Schirmer's Test

    Time frame: Follow-up period, up to 3 months

    Degree of improvement of tear production according to Schirmer's test evaluated at 3 months after end of treatment period.

  14. Tear Meniscus Height (TMH)

    Time frame: Follow-up period, up to 1 month

    Degree of change in TMH value evaluated at 1 month after end of treatment period.

  15. Tear Meniscus Height (TMH)

    Time frame: Follow-up period, up to 3 months

    Degree of change in TMH value evaluated at 3 months after end of treatment period.

  16. Lissamine Green Test

    Time frame: Follow-up period, up to 1 month

    Lissamine green test scale changes evaluated at 1 month after end of treatment period.

  17. Lissamine Green Test

    Time frame: Follow-up period, up to 3 months

    Lissamine green test scale changes evaluated at 3 months after end of treatment period.

  18. Corneal Staining Test

    Time frame: Follow-up period, up to 1 month

    Corneal Staining test scale changes evaluated at 1 month after end of treatment period.

  19. Corneal Staining Test

    Time frame: Follow-up period, up to 3 months

    Corneal Staining test scale changes evaluated at 3 months after end of treatment period.

  20. Lipid Layer Test

    Time frame: Follow-up period, up to 1 month

    Degree of improvement of Lipid Layer coverage and thickness evaluated at 1 month after end of treatment.

    The test is performed with a specific interference camera that visualizes the pre corneal lipid layer spread. The Interference colour chart allows quantification of the interference images, which are graded corresponding to lipid layer thickness and coverage. Images are classified from 5 grades; 1. Open meshwork, 2. Open to closed meshwork, 3. Closed to open meshwork, 4 Closed meshwork, 5. Colour fringe

  21. Lipid Layer Test

    Time frame: Follow-up period, up to 3 months

    Degree of improvement of Lipid Layer coverage and thickness evaluated at 3 months after end of treatment.

    The test is performed with a specific interference camera that visualizes the pre corneal lipid layer spread. The Interference colour chart allows quantification of the interference images, which are graded corresponding to lipid layer thickness and coverage. Images are classified from 5 grades; 1. Open meshwork, 2. Open to closed meshwork, 3. Closed to open meshwork, 4 Closed meshwork, 5. Colour fringe

  22. Compliance

    Time frame: Study period, up to 4.5 months

    Grade of compliance/adherence to prescribed treatment.

Sponsors and collaborators

Lead sponsor

Abilion Medical Systems AB

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2023
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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