Dry Eye, Dry Eye Syndromes
Conditions
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.
Interventions
DEVICEWalther System
Walther System providing INMEST treatment
DEVICESham Walther System
Walther System not providing INMEST treatment, but otherwise behave as the active comparator.
DRUGNon preserved ocular lubricants
* Hyaluronic acid (HyloGel) * Hyaluronic acid and Ectoin (Hylo Dual Intense) * Hyaluronic acid and Trehalos (Theloz Duo)
PROCEDUREEye lid procedure
Lid hygiene, warm eye bag, lid massage and Omega 3
Sponsors
Abilion Medical Systems AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Pivotal, double-blind, randomized, multicentre study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Non-Invasive Tear Break-Up time (NIBUT) | Treatment period, up to 6 weeks | Degree of increased Non-Invasive tear Break-Up time. Baseline result compared to result measured during treatment period. |
| Schirmer's Test | Treatment period, up to 6 weeks | Degree of improvement of tear production according to Schirmer's test. Baseline result compared to result measured during treatment period. |
| 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. |
| Lissamine Green Test | Treatment period, up to 6 weeks | Lissamine green test scale changes. Baseline scale compared with scale measured during treatment period. |
| Corneal Staining Test | Treatment period, up to 6 weeks | Corneal Staining test scale changes. Baseline scale compared with scale measured during treatment period. |
| Lipid Layer Test | Treatment period, up to 6 weeks | 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 |
| Compliance | Study period, up to 4.5 months | Grade of compliance/adherence to prescribed treatment. |
| Tear Meniscus Height (TMH) | Treatment period, up to 6 weeks | Degree of change in TMH value. Baseline value compared to value measured during treatment period. |
Countries
Denmark, Sweden
Outcome results
None listed