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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887336
• Other study ID #: A-DE-002
• Status: Recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Abilion Medical Systems AB
• Contact: Karl-Johan Pantzar
• Phone: +46739808065
• Email: kj[@]abilion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Walther System
Walther System providing INMEST treatment
• 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

Locations

Country	Name	City	State
Denmark	Kontaktlinse Instituttet	Århus
Denmark	Øjenhospitalet Danmark	Charlottenlund	Copenhagen
Sweden	Källmarkskliniken	Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Abilion Medical Systems AB

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ocular Surface Disease Index (OSDI)	Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.	Treatment period, up to 6 weeks
Secondary	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.	Study period, up to 4.5 months
Secondary	Device Deficiencies	Number of Walther System Device Deficiencies.	Treatment period, up to 6 weeks
Secondary	Remission	Remission of estimated symptoms with OSDI after a treatment period of 6 weeks evaluated as a binary endpoint.	Treatment period, up to 6 weeks
Secondary	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.	Treatment period, up to 6 weeks
Secondary	Schirmer's Test	Degree of improvement of tear production according to Schirmer's test. Baseline result compared to result measured during treatment period.	Treatment period, up to 6 weeks
Secondary	Tear Meniscus Height (TMH)	Degree of change in TMH value. Baseline value compared to value measured during treatment period.	Treatment period, up to 6 weeks
Secondary	Lissamine Green Test	Lissamine green test scale changes. Baseline scale compared with scale measured during treatment period.	Treatment period, up to 6 weeks
Secondary	Corneal Staining Test	Corneal Staining test scale changes. Baseline scale compared with scale measured during treatment period.	Treatment period, up to 6 weeks
Secondary	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	Treatment period, up to 6 weeks
Secondary	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.	Follow-up period, up to 1 month
Secondary	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.	Follow-up period, up to 3 months
Secondary	Schirmer's Test	Degree of improvement of tear production according to Schirmer's test evaluated at 1 month after end of treatment period.	Follow-up period, up to 1 month
Secondary	Schirmer's Test	Degree of improvement of tear production according to Schirmer's test evaluated at 3 months after end of treatment period.	Follow-up period, up to 3 months
Secondary	Tear Meniscus Height (TMH)	Degree of change in TMH value evaluated at 1 month after end of treatment period.	Follow-up period, up to 1 month
Secondary	Tear Meniscus Height (TMH)	Degree of change in TMH value evaluated at 3 months after end of treatment period.	Follow-up period, up to 3 months
Secondary	Lissamine Green Test	Lissamine green test scale changes evaluated at 1 month after end of treatment period.	Follow-up period, up to 1 month
Secondary	Lissamine Green Test	Lissamine green test scale changes evaluated at 3 months after end of treatment period.	Follow-up period, up to 3 months
Secondary	Corneal Staining Test	Corneal Staining test scale changes evaluated at 1 month after end of treatment period.	Follow-up period, up to 1 month
Secondary	Corneal Staining Test	Corneal Staining test scale changes evaluated at 3 months after end of treatment period.	Follow-up period, up to 3 months
Secondary	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	Follow-up period, up to 1 month
Secondary	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	Follow-up period, up to 3 months
Secondary	Compliance	Grade of compliance/adherence to prescribed treatment.	Study period, up to 4.5 months