Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)

Study Overview
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Brief Summary
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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.

Official Title
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Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)

Conditions
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Keratoconjunctivitis Sicca (KCS)

Intervention / Treatment
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* Device: KCS Medical Device
* Device: KCS Medical Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ocular surface disease index, OSDI > 12 points. Non-invasive breakup time, NIBUT < 11 seconds. Exclusion Criteria: Ocular surface disease index, OSDI < 12 points. Non-invasive breakup time, NIBUT > 11 seconds.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded randomised clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active KCS Medical Device<br> | Device: KCS Medical Device<br>* Patient treated 6 times with the Active KCS Medical Device during 2 weeks.<br>|
| Placebo Comparator: Inactive KCS Medical Device<br> | Device: KCS Medical Device<br>* Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |