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

• Sponsor: Abilion Medical Systems AB (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05887336
• Collaborator: (none)
• Enrollment: 110
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site: 36.7
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye; Dry Eye Syndromes	Device: Walther System; Device: Sham Walther System; Drug: Non preserved ocular lubricants; Procedure: Eye lid procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pivotal, double-blind, randomized, multicentre study.Pivotal, double-blind, randomized, multicentre study.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Investigational device treament and standard treatment After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.	Device: Walther System; Walther System providing INMEST treatment; 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
Sham Comparator: Sham device treatment and standard treatment After an initial demonstration of the device, study subjects will be given the device to be used for self-administration at home, 10 minutes per day in each nasal cavity, 3 days a week, for a total treatment period of six weeks.	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

Outcome Measures

Primary Outcome Measures

1. Change in Ocular Surface Disease Index (OSDI) [Treatment period, up to 6 weeks]

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

Secondary Outcome Measures

1. Adverse Events [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 [Treatment period, up to 6 weeks]

   Number of Walther System Device Deficiencies.

3. Remission [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) [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 [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) [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 [Treatment period, up to 6 weeks]

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

8. Corneal Staining Test [Treatment period, up to 6 weeks]

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

9. Lipid Layer Test [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) [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) [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 [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 [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) [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) [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 [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 [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 [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 [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 [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 [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 [Study period, up to 4.5 months]

    Grade of compliance/adherence to prescribed treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 or have 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 approved form 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 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 study start (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 adequate understanding or cooperation

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

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Øjenhospitalet Danmark	Charlottenlund	Copenhagen	Denmark	2920
2	Kontaktlinse Instituttet	Århus		Denmark
3	Källmarkskliniken	Solna	Stockholm	Sweden	171 54

Sponsors and Collaborators

• Abilion Medical Systems AB

Investigators

• Principal Investigator: Fredrik Källmark, PhD, Källmarkskliniken

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abilion Medical Systems AB
• ClinicalTrials.gov Identifier: NCT05887336
• Other Study ID Numbers: A-DE-002
• First Posted: Jun 2, 2023
• Last Update Posted: Jun 2, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Jun 2, 2023