Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye
NCT ID: NCT05887336
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2023-06-01
2024-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Walther System
Walther System providing INMEST treatment
Non preserved ocular lubricants
* Hyaluronic acid (HyloGel)
* Hyaluronic acid and Ectoin (Hylo Dual Intense)
* Hyaluronic acid and Trehalos (Theloz Duo)
Eye lid procedure
Lid hygiene, warm eye bag, lid massage and Omega 3
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.
Sham Walther System
Walther System not providing INMEST treatment, but otherwise behave as the active comparator.
Non preserved ocular lubricants
* Hyaluronic acid (HyloGel)
* Hyaluronic acid and Ectoin (Hylo Dual Intense)
* Hyaluronic acid and Trehalos (Theloz Duo)
Eye lid procedure
Lid hygiene, warm eye bag, lid massage and Omega 3
Interventions
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Walther System
Walther System providing INMEST treatment
Sham Walther System
Walther System not providing INMEST treatment, but otherwise behave as the active comparator.
Non preserved ocular lubricants
* Hyaluronic acid (HyloGel)
* Hyaluronic acid and Ectoin (Hylo Dual Intense)
* Hyaluronic acid and Trehalos (Theloz Duo)
Eye lid procedure
Lid hygiene, warm eye bag, lid massage and Omega 3
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Abilion Medical Systems AB
INDUSTRY
Responsible Party
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Principal Investigators
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Fredrik Källmark, PhD
Role: PRINCIPAL_INVESTIGATOR
Källmarkskliniken
Locations
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Øjenhospitalet Danmark
Charlottenlund, Copenhagen, Denmark
Kontaktlinse Instituttet
Aarhus, Århus, Denmark
Källmarkskliniken
Solna, Stockholm County, Sweden
Countries
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Other Identifiers
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A-DE-002
Identifier Type: -
Identifier Source: org_study_id
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