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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device treament and standard treatment | Active Comparator | 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. |
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| Sham device treatment and standard treatment | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walther System | Device | Walther System providing INMEST treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Device Deficiencies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredrik Källmark, PhD | Källmarkskliniken | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Øjenhospitalet Danmark | Charlottenlund | Copenhagen | 2920 | Denmark | ||
| Kontaktlinse Instituttet |
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Pivotal, double-blind, randomized, multicentre study.
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| Sham Walther System | Device | Walther System not providing INMEST treatment, but otherwise behave as the active comparator. |
|
| Non preserved ocular lubricants | Drug |
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| Eye lid procedure | Procedure | Lid hygiene, warm eye bag, lid massage and Omega 3 |
|
Number of Walther System Device Deficiencies. |
| 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. | 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. | 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. | 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. | Treatment period, up to 6 weeks |
| Lissamine Green Test | Lissamine green test scale changes. Baseline scale compared with scale measured during treatment period. | Treatment period, up to 6 weeks |
| Corneal Staining Test | Corneal Staining test scale changes. Baseline scale compared with scale measured during treatment period. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | Follow-up period, up to 3 months |
| Lissamine Green Test | Lissamine green test scale changes evaluated at 1 month after end of treatment period. | Follow-up period, up to 1 month |
| Lissamine Green Test | Lissamine green test scale changes evaluated at 3 months after end of treatment period. | Follow-up period, up to 3 months |
| Corneal Staining Test | Corneal Staining test scale changes evaluated at 1 month after end of treatment period. | Follow-up period, up to 1 month |
| Corneal Staining Test | Corneal Staining test scale changes evaluated at 3 months after end of treatment period. | 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 | 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 | Follow-up period, up to 3 months |
| Compliance | Grade of compliance/adherence to prescribed treatment. | Study period, up to 4.5 months |
| Aarhus |
| Århus |
| Denmark |
| Källmarkskliniken | Solna | Stockholm County | 171 54 | Sweden |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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