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| Name | Class |
|---|---|
| Källmark Clinic | OTHER |
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The purpose of the study is to evaluate how treatment with Intra-Nasal Mechanical Stimulation (INMEST) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active KCS Medical Device | Experimental |
| |
| Inactive KCS Medical Device | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KCS Medical Device | Device | Patient treated 6 times with the Active KCS Medical Device during 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular surface disease index, OSDI | 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Scale 0-100, normal value range 0-12. | Change from Baseline Ocular surface disease index at two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Noninvasive breakup time, NIBUT | Assessment of tear film stability. Normal value at least 11 seconds. | Change from Baseline Noninvasive breakup time at two weeks. |
| Meibography | Imaging study method for directly visualizing the morphology of Meibomian glands in vivo. Fat amount in the Meibomian glands is quantified and stated in percent. A Meibo scale value over 25 % is considered abnormal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan-Erik Juto, M.D., Ph.D. | Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Källmarkskliniken | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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Double blinded randomised clinical trial
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Placebo device
| KCS Medical Device | Device | Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks. |
|
| Change from Baseline Meibo scale value at two weeks. |
| Phenol Red Thread Test, PRT | Measurement of lacrimation, stated in millimetres. Normal value is 12-20 millimetres. | Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks. |
| Tear (lacrimal) meniscus height | Tear meniscus height measured medially on the lower eyelid. Stated in millimetres. Normal value is over 0,2 mm. | Change from Baseline Tear (lacrimal) meniscus height at two weeks. |
| Lissamin green test | A strip of paper containing lissamine green is diluted with saline, and then dropped into the eye. The colour of the paper will disclose any dry cell patches in the eye. | Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks. |
| Corneal staining with fluorescein | Fluorescein is used to describe the severity of damaged epithelial cells on cornea. Efron Grading Scale, 1-5. 0 is normal value. | Change from Baseline Efron Grading Scale value at two weeks. |
| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |