Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)
| Registry | NCT03418259 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 70 (Actual) |
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| Sponsor | Karolinska Institutet (Other); collaborators: Källmark Clinic |
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| Conditions | Keratoconjunctivitis Sicca (KCS) |
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| Interventions | KCS Medical Device (Device) |
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| Dates | start 2018-02-12, primary completion 2022-07-01, completion 2022-07-01, first posted 2018-02-01, last updated 2022-12-13 |
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| Locations | 1 site in Sweden |
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-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Active KCS Medical Device | Experimental | Device: KCS Medical Device | |
| Inactive KCS Medical Device | Placebo comparator | Device: KCS Medical Device | |
- KCS Medical Device (Device): Patient treated 6 times with the Active KCS Medical Device during 2 weeks.
- KCS Medical Device (Device): Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.
+Outcome measures
Primary outcomes
- Ocular surface disease index, OSDI [Change from Baseline Ocular surface disease index at two weeks.]: 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.
Secondary outcomes
- Noninvasive breakup time, NIBUT [Change from Baseline Noninvasive breakup time at two weeks.]: Assessment of tear film stability. Normal value at least 11 seconds.
- Meibography [Change from Baseline Meibo scale value at two weeks.]: 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.
- Phenol Red Thread Test, PRT [Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks.]: Measurement of lacrimation, stated in millimetres. Normal value is 12-20 millimetres.
- Tear (lacrimal) meniscus height [Change from Baseline Tear (lacrimal) meniscus height at two weeks.]: Tear meniscus height measured medially on the lower eyelid. Stated in millimetres. Normal value is over 0,2 mm.
- Lissamin green test [Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks.]: 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.
- Corneal staining with fluorescein [Change from Baseline Efron Grading Scale value at two weeks.]: Fluorescein is used to describe the severity of damaged epithelial cells on cornea. Efron Grading Scale, 1-5. 0 is normal value.
+Eligibility
Sex: All, ages: 20 Years to 75 Years
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.
+Locations (1)
| Facility | City | Country | Status |
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| Källmarkskliniken | Stockholm | Sweden | |
+Investigators
- Jan-Erik Juto, M.D., Ph.D., Principal investigator, Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet