Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03418259 |
|
Recruitment Status : Unknown
Verified February 2020 by Jan-Erik Juto, Karolinska Institutet.
Recruitment status was: Recruiting
First Posted : February 1, 2018
Last Update Posted : February 11, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Keratoconjunctivitis Sicca (KCS) | Device: KCS Medical Device | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Double blinded randomised clinical trial |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Placebo device |
| Primary Purpose: | Treatment |
| Official Title: | Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST) |
| Actual Study Start Date : | February 12, 2018 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Active KCS Medical Device |
Device: KCS Medical Device
Patient treated 6 times with the Active KCS Medical Device during 2 weeks. |
| Placebo Comparator: Inactive KCS Medical Device |
Device: KCS Medical Device
Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks. |
- Ocular surface disease index, OSDI [ Time Frame: 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.
- Noninvasive breakup time, NIBUT [ Time Frame: Change from Baseline Noninvasive breakup time at two weeks. ]Assessment of tear film stability. Normal value at least 11 seconds.
- Meibography [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418259
| Contact: Jan-Erik Juto, M.D., Ph.D. | +46768830709 | jan-erik.juto@ki.se |
| Sweden | |
| Källmarkskliniken | Recruiting |
| Stockholm, Sweden | |
| Contact: Fredrik Källmark, B.Sc., Ph.D. | |
| Principal Investigator: | Jan-Erik Juto, M.D., Ph.D. | Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet |
| Responsible Party: | Jan-Erik Juto, Principal Investigator, M.D., Ph.D., Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT03418259 |
| Other Study ID Numbers: |
INMESTfordryeyes2018 |
| First Posted: | February 1, 2018 Key Record Dates |
| Last Update Posted: | February 11, 2020 |
| Last Verified: | February 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Dry Eye Syndromes Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases |
Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases |

