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

Primary Purpose

Dry Eye, Dry Eye Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Walther System
Sham Walther System
Non preserved ocular lubricants
Eye lid procedure
Sponsored by
Abilion Medical Systems AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Øjenhospitalet Danmark
  • Kontaktlinse Instituttet
  • KällmarksklinikenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Investigational device treament and standard treatment

Sham device treatment and standard treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events
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
Number of Walther System Device Deficiencies.
Remission
Remission of estimated symptoms with OSDI after a treatment period of 6 weeks evaluated as a binary endpoint.
Non-Invasive Tear Break-Up time (NIBUT)
Degree of increased Non-Invasive tear Break-Up time. Baseline result compared to result measured during treatment period.
Schirmer's Test
Degree of improvement of tear production according to Schirmer's test. Baseline result compared to result measured during treatment period.
Tear Meniscus Height (TMH)
Degree of change in TMH value. Baseline value compared to value measured during treatment period.
Lissamine Green Test
Lissamine green test scale changes. Baseline scale compared with scale measured during treatment period.
Corneal Staining Test
Corneal Staining test scale changes. Baseline scale compared with scale measured during treatment period.
Lipid Layer Test
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
Non-Invasive Tear Break-Up time (NIBUT)
Degree of increased Non-Invasive tear Break-Up time evaluated at 1 month after end of treatment period.
Non-Invasive Tear Break-Up time (NIBUT)
Degree of increased Non-Invasive tear Break-Up time evaluated at 3 months after end of treatment period.
Schirmer's Test
Degree of improvement of tear production according to Schirmer's test evaluated at 1 month after end of treatment period.
Schirmer's Test
Degree of improvement of tear production according to Schirmer's test evaluated at 3 months after end of treatment period.
Tear Meniscus Height (TMH)
Degree of change in TMH value evaluated at 1 month after end of treatment period.
Tear Meniscus Height (TMH)
Degree of change in TMH value evaluated at 3 months after end of treatment period.
Lissamine Green Test
Lissamine green test scale changes evaluated at 1 month after end of treatment period.
Lissamine Green Test
Lissamine green test scale changes evaluated at 3 months after end of treatment period.
Corneal Staining Test
Corneal Staining test scale changes evaluated at 1 month after end of treatment period.
Corneal Staining Test
Corneal Staining test scale changes evaluated at 3 months after end of treatment period.
Lipid Layer Test
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
Lipid Layer Test
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
Compliance
Grade of compliance/adherence to prescribed treatment.

Full Information

First Posted
May 23, 2023
Last Updated
June 1, 2023
Sponsor
Abilion Medical Systems AB
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1. Study Identification

Unique Protocol Identification Number
NCT05887336
Brief Title
Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment Method for the Relief of Symptoms of Dry Eye
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abilion Medical Systems AB

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pivotal, double-blind, randomized, multicentre study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational device treament and standard treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham device treatment and standard treatment
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Walther System
Intervention Description
Walther System providing INMEST treatment
Intervention Type
Device
Intervention Name(s)
Sham Walther System
Intervention Description
Walther System not providing INMEST treatment, but otherwise behave as the active comparator.
Intervention Type
Drug
Intervention Name(s)
Non preserved ocular lubricants
Intervention Description
Hyaluronic acid (HyloGel) Hyaluronic acid and Ectoin (Hylo Dual Intense) Hyaluronic acid and Trehalos (Theloz Duo)
Intervention Type
Procedure
Intervention Name(s)
Eye lid procedure
Intervention Description
Lid hygiene, warm eye bag, lid massage and Omega 3
Primary Outcome Measure Information:
Title
Change in Ocular Surface Disease Index (OSDI)
Description
Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.
Time Frame
Treatment period, up to 6 weeks
Secondary Outcome Measure Information:
Title
Adverse Events
Description
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.
Time Frame
Study period, up to 4.5 months
Title
Device Deficiencies
Description
Number of Walther System Device Deficiencies.
Time Frame
Treatment period, up to 6 weeks
Title
Remission
Description
Remission of estimated symptoms with OSDI after a treatment period of 6 weeks evaluated as a binary endpoint.
Time Frame
Treatment period, up to 6 weeks
Title
Non-Invasive Tear Break-Up time (NIBUT)
Description
Degree of increased Non-Invasive tear Break-Up time. Baseline result compared to result measured during treatment period.
Time Frame
Treatment period, up to 6 weeks
Title
Schirmer's Test
Description
Degree of improvement of tear production according to Schirmer's test. Baseline result compared to result measured during treatment period.
Time Frame
Treatment period, up to 6 weeks
Title
Tear Meniscus Height (TMH)
Description
Degree of change in TMH value. Baseline value compared to value measured during treatment period.
Time Frame
Treatment period, up to 6 weeks
Title
Lissamine Green Test
Description
Lissamine green test scale changes. Baseline scale compared with scale measured during treatment period.
Time Frame
Treatment period, up to 6 weeks
Title
Corneal Staining Test
Description
Corneal Staining test scale changes. Baseline scale compared with scale measured during treatment period.
Time Frame
Treatment period, up to 6 weeks
Title
Lipid Layer Test
Description
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
Time Frame
Treatment period, up to 6 weeks
Title
Non-Invasive Tear Break-Up time (NIBUT)
Description
Degree of increased Non-Invasive tear Break-Up time evaluated at 1 month after end of treatment period.
Time Frame
Follow-up period, up to 1 month
Title
Non-Invasive Tear Break-Up time (NIBUT)
Description
Degree of increased Non-Invasive tear Break-Up time evaluated at 3 months after end of treatment period.
Time Frame
Follow-up period, up to 3 months
Title
Schirmer's Test
Description
Degree of improvement of tear production according to Schirmer's test evaluated at 1 month after end of treatment period.
Time Frame
Follow-up period, up to 1 month
Title
Schirmer's Test
Description
Degree of improvement of tear production according to Schirmer's test evaluated at 3 months after end of treatment period.
Time Frame
Follow-up period, up to 3 months
Title
Tear Meniscus Height (TMH)
Description
Degree of change in TMH value evaluated at 1 month after end of treatment period.
Time Frame
Follow-up period, up to 1 month
Title
Tear Meniscus Height (TMH)
Description
Degree of change in TMH value evaluated at 3 months after end of treatment period.
Time Frame
Follow-up period, up to 3 months
Title
Lissamine Green Test
Description
Lissamine green test scale changes evaluated at 1 month after end of treatment period.
Time Frame
Follow-up period, up to 1 month
Title
Lissamine Green Test
Description
Lissamine green test scale changes evaluated at 3 months after end of treatment period.
Time Frame
Follow-up period, up to 3 months
Title
Corneal Staining Test
Description
Corneal Staining test scale changes evaluated at 1 month after end of treatment period.
Time Frame
Follow-up period, up to 1 month
Title
Corneal Staining Test
Description
Corneal Staining test scale changes evaluated at 3 months after end of treatment period.
Time Frame
Follow-up period, up to 3 months
Title
Lipid Layer Test
Description
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
Time Frame
Follow-up period, up to 1 month
Title
Lipid Layer Test
Description
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
Time Frame
Follow-up period, up to 3 months
Title
Compliance
Description
Grade of compliance/adherence to prescribed treatment.
Time Frame
Study period, up to 4.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl-Johan Pantzar
Phone
+46739808065
Email
kj@abilion.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jan-Erik Juto, PhD
Phone
+46723310709
Email
janerikjuto@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Källmark, PhD
Organizational Affiliation
Källmarkskliniken
Official's Role
Principal Investigator
Facility Information:
Facility Name
Øjenhospitalet Danmark
City
Charlottenlund
State/Province
Copenhagen
ZIP/Postal Code
2920
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Lønsmann Poulsen, MD
Phone
+45 41512361
Email
jlp@ohd.dk
Facility Name
Kontaktlinse Instituttet
City
Århus
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Lauenborg, Optometrist
Phone
+45 86137911
Email
bo@kontaktlinseinstituttet.dk
Facility Name
Källmarkskliniken
City
Solna
State/Province
Stockholm
ZIP/Postal Code
171 54
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Källmark, PhD
Phone
+46 8 7520100
Email
info@kallmarkskliniken.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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