Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 6:32 PM
Study NCT ID:
NCT03418259
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2018-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Placebo device'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blinded randomised clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-11', 'studyFirstSubmitDate': '2018-01-19', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular surface disease index, OSDI', 'timeFrame': 'Change from Baseline Ocular surface disease index at two weeks.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Noninvasive breakup time, NIBUT', 'timeFrame': 'Change from Baseline Noninvasive breakup time at two weeks.', 'description': 'Assessment of tear film stability. Normal value at least 11 seconds.'}, {'measure': 'Meibography', 'timeFrame': 'Change from Baseline Meibo scale value at two weeks.', 'description': '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.'}, {'measure': 'Phenol Red Thread Test, PRT', 'timeFrame': 'Change from Baseline lacrimation assessed with Phenol Red Thread Test value at two weeks.', 'description': 'Measurement of lacrimation, stated in millimetres. Normal value is 12-20 millimetres.'}, {'measure': 'Tear (lacrimal) meniscus height', 'timeFrame': 'Change from Baseline Tear (lacrimal) meniscus height at two weeks.', 'description': 'Tear meniscus height measured medially on the lower eyelid. Stated in millimetres. Normal value is over 0,2 mm.'}, {'measure': 'Lissamin green test', 'timeFrame': 'Change from Baseline spread of dry cell patches quantified with Lissamin green test at two weeks.', 'description': '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.'}, {'measure': 'Corneal staining with fluorescein', 'timeFrame': 'Change from Baseline Efron Grading Scale value at two weeks.', 'description': 'Fluorescein is used to describe the severity of damaged epithelial cells on cornea. Efron Grading Scale, 1-5. 0 is normal value.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratoconjunctivitis Sicca (KCS)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ocular surface disease index, OSDI \\> 12 points.\n* Non-invasive breakup time, NIBUT \\< 11 seconds.\n\nExclusion Criteria:\n\n* Ocular surface disease index, OSDI \\< 12 points.\n* Non-invasive breakup time, NIBUT \\> 11 seconds.'}, 'identificationModule': {'nctId': 'NCT03418259', 'briefTitle': 'Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye Syndrome)', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Study of Patients With Dry Eyes, Keratoconjunctivitis Sicca, During Treatment With Intra-Nasal Mechanical Stimulation (INMEST)', 'orgStudyIdInfo': {'id': 'INMESTfordryeyes2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active KCS Medical Device', 'interventionNames': ['Device: KCS Medical Device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inactive KCS Medical Device', 'interventionNames': ['Device: KCS Medical Device']}], 'interventions': [{'name': 'KCS Medical Device', 'type': 'DEVICE', 'description': 'Patient treated 6 times with the Active KCS Medical Device during 2 weeks.', 'armGroupLabels': ['Active KCS Medical Device']}, {'name': 'KCS Medical Device', 'type': 'DEVICE', 'description': 'Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.', 'armGroupLabels': ['Inactive KCS Medical Device']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Källmarkskliniken', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Jan-Erik Juto, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), H9, Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Källmark Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, M.D., Ph.D.', 'investigatorFullName': 'Jan-Erik Juto', 'investigatorAffiliation': 'Karolinska Institutet'}}}}