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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
Walther System providing INMEST treatment
Walther System not providing INMEST treatment, but otherwise behave as the active comparator.
* Hyaluronic acid (HyloGel) * Hyaluronic acid and Ectoin (Hylo Dual Intense) * Hyaluronic acid and Trehalos (Theloz Duo)
Lid hygiene, warm eye bag, lid massage and Omega 3
Øjenhospitalet Danmark
Charlottenlund, Copenhagen, Denmark
Kontaktlinse Instituttet
Aarhus, Århus, Denmark
Källmarkskliniken
Solna, Stockholm County, Sweden
Change in Ocular Surface Disease Index (OSDI)
Change in Ocular Surface Disease Index (OSDI) evaluated at baseline and end of treatment.
Time frame: Treatment period, up to 6 weeks
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.
Time frame: Study period, up to 4.5 months
Device Deficiencies
Number of Walther System Device Deficiencies.
Time frame: Treatment period, up to 6 weeks
Remission
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
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.
Time frame: Treatment period, up to 6 weeks
Schirmer's Test
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
Tear Meniscus Height (TMH)
Degree of change in TMH value. Baseline value compared to value measured during treatment period.
Time frame: Treatment period, up to 6 weeks
Lissamine Green Test
Lissamine green test scale changes. Baseline scale compared with scale measured during treatment period.
Time frame: Treatment period, up to 6 weeks
Corneal Staining Test
Corneal Staining test scale changes. Baseline scale compared with scale measured during treatment period.
Time frame: Treatment period, up to 6 weeks
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
Time frame: Treatment period, up to 6 weeks
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.
Time frame: Follow-up period, up to 1 month
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.
Time frame: Follow-up period, up to 3 months
Schirmer's Test
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
Schirmer's Test
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
Tear Meniscus Height (TMH)
Degree of change in TMH value evaluated at 1 month after end of treatment period.
Time frame: Follow-up period, up to 1 month
Tear Meniscus Height (TMH)
Degree of change in TMH value evaluated at 3 months after end of treatment period.
Time frame: Follow-up period, up to 3 months
Lissamine Green Test
Lissamine green test scale changes evaluated at 1 month after end of treatment period.
Time frame: Follow-up period, up to 1 month
Lissamine Green Test
Lissamine green test scale changes evaluated at 3 months after end of treatment period.
Time frame: Follow-up period, up to 3 months
Corneal Staining Test
Corneal Staining test scale changes evaluated at 1 month after end of treatment period.
Time frame: Follow-up period, up to 1 month
Corneal Staining Test
Corneal Staining test scale changes evaluated at 3 months after end of treatment period.
Time frame: Follow-up period, up to 3 months
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
Time frame: Follow-up period, up to 1 month
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
Time frame: Follow-up period, up to 3 months
Compliance
Grade of compliance/adherence to prescribed treatment.
Time frame: Study period, up to 4.5 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.