Clinical trial NCT05887336: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Dry Eye Syndromes
Lead sponsor: Abilion Medical Systems AB
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pivotal, double-blind, randomized, multicentre study.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI)
timeFrame: Treatment period, up to 6 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: Study period, up to 4.5 months
measure: Device Deficiencies
timeFrame: Treatment period, up to 6 weeks
measure: Remission
timeFrame: Treatment period, up to 6 weeks
measure: Non-Invasive Tear Break-Up time (NIBUT)
timeFrame: Treatment period, up to 6 weeks
measure: Schirmer's Test
timeFrame: Treatment period, up to 6 weeks
measure: Tear Meniscus Height (TMH)
timeFrame: Treatment period, up to 6 weeks
measure: Lissamine Green Test
timeFrame: Treatment period, up to 6 weeks
measure: Corneal Staining Test
timeFrame: Treatment period, up to 6 weeks
measure: Lipid Layer Test
timeFrame: Treatment period, up to 6 weeks
measure: Non-Invasive Tear Break-Up time (NIBUT)
timeFrame: Follow-up period, up to 1 month
measure: Non-Invasive Tear Break-Up time (NIBUT)
timeFrame: Follow-up period, up to 3 months
measure: Schirmer's Test
timeFrame: Follow-up period, up to 1 month
measure: Schirmer's Test
timeFrame: Follow-up period, up to 3 months
measure: Tear Meniscus Height (TMH)
timeFrame: Follow-up period, up to 1 month
measure: Tear Meniscus Height (TMH)
timeFrame: Follow-up period, up to 3 months
measure: Lissamine Green Test
timeFrame: Follow-up period, up to 1 month
measure: Lissamine Green Test
timeFrame: Follow-up period, up to 3 months
measure: Corneal Staining Test
timeFrame: Follow-up period, up to 1 month
measure: Corneal Staining Test
timeFrame: Follow-up period, up to 3 months
measure: Lipid Layer Test
timeFrame: Follow-up period, up to 1 month
measure: Lipid Layer Test
timeFrame: Follow-up period, up to 3 months
measure: Compliance
timeFrame: Study period, up to 4.5 months
Other outcomes:
Locations:
city: Charlottenlund
country: Denmark
facility: Øjenhospitalet Danmark
state: Copenhagen
city: Århus
country: Denmark
facility: Kontaktlinse Instituttet
city: Solna
country: Sweden
facility: Källmarkskliniken
state: Stockholm
Study officials:
affiliation: Källmarkskliniken
name: Fredrik Källmark, PhD
role: PRINCIPAL_INVESTIGATOR
References: