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

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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
Sponsor:
Collaborator:
Källmark Clinic
Information provided by (Responsible Party):
Jan-Erik Juto, Karolinska Institutet

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca (KCS) Device: KCS Medical Device Not Applicable

Study Design
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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
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jan-Erik Juto, M.D., Ph.D. +46768830709 jan-erik.juto@ki.se

Locations
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Sweden
Källmarkskliniken Recruiting
Stockholm, Sweden
Contact: Fredrik Källmark, B.Sc., Ph.D.         
Sponsors and Collaborators
Karolinska Institutet
Källmark Clinic
Investigators
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Principal Investigator: Jan-Erik Juto, M.D., Ph.D. Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases