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

Not Applicable

Completed

• Conditions: Dry Eye; Dry Eye Syndromes
• Interventions: Device: Walther System; Device: Sham Walther System; Drug: Non preserved ocular lubricants; Procedure: Eye lid procedure

• Registration Number: NCT05887336
• Lead Sponsor: Abilion Medical Systems AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-02
• Primary Completion: 2024-08-01
• Study Completion: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham device treatment and standard treatment	Non preserved ocular lubricants	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.
Investigational device treament and standard treatment	Walther System	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.
Investigational device treament and standard treatment	Non preserved ocular lubricants	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.
Sham device treatment and standard treatment	Sham Walther System	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.
Investigational device treament and standard treatment	Eye lid procedure	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.
Sham device treatment and standard treatment	Eye lid procedure	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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
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.
Device Deficiencies	Treatment period, up to 6 weeks	Number of Walther System Device Deficiencies.
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.
Corneal Staining Test	Follow-up period, up to 3 months	Corneal Staining test scale changes evaluated at 3 months after end of treatment period.
Compliance	Study period, up to 4.5 months	Grade of compliance/adherence to prescribed treatment.
Lissamine Green Test	Follow-up period, up to 3 months	Lissamine green test scale changes evaluated at 3 months after end of treatment period.

Trial Locations

Locations (3)

Källmarkskliniken; 🇸🇪 Solna, Stockholm, Sweden

Øjenhospitalet Danmark; 🇩🇰 Charlottenlund, Copenhagen, Denmark

Kontaktlinse Instituttet; 🇩🇰 Århus, Denmark