Keratoconjunctivitis Sicca (KCS) Clinical Trial
Official title:
Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)
Verified date | December 2022 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Källmarkskliniken | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Källmark Clinic |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Noninvasive breakup time, NIBUT | Assessment of tear film stability. Normal value at least 11 seconds. | Change from Baseline Noninvasive breakup time at two weeks. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |