An interventional study of KCS Medical Device and KCS Medical Device in Keratoconjunctivitis Sicca (KCS), sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Device: KCS Medical Device
Device: KCS Medical Device
Patient treated 6 times with the Active KCS Medical Device during 2 weeks.
Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.
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.
Time frame: Change from Baseline Ocular surface disease index at two weeks.
Noninvasive breakup time, NIBUT
Assessment of tear film stability. Normal value at least 11 seconds.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline Efron Grading Scale value at two weeks.
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Karolinska Institutet