Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-01 @ 8:56 AM
Study NCT ID:
NCT02385292
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2015-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'The investigator or other study-related personnel may not disclose to anyone or use any data, information, or materials related to this clinical trial without the express written consent of Oculeve.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.'}}, 'adverseEventsModule': {'description': 'During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.', 'eventGroups': [{'id': 'EG000', 'title': 'Intranasal Application', 'description': 'Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Extranasal Application', 'description': 'Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fluorescein Tear Clearance With Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Application', 'description': 'Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}, {'id': 'OG001', 'title': 'Extranasal Application', 'description': 'Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Level of Tear Proteins Pre and Post Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Application', 'description': 'Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}, {'id': 'OG001', 'title': 'Extranasal Application', 'description': 'Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Level of Inflammatory Mediators Pre and Post Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Application', 'description': 'Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}, {'id': 'OG001', 'title': 'Extranasal Application', 'description': 'Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Goblet Cell Count Following Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Application', 'description': 'Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}, {'id': 'OG001', 'title': 'Extranasal Application', 'description': 'Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}], 'timeFrame': 'Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intranasal Then Extranasal Application', 'description': 'Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}, {'id': 'FG001', 'title': 'Extranasal Then Intranasal Application', 'description': 'Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intranasal Then Extranasal Application', 'description': 'Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}, {'id': 'BG001', 'title': 'Extranasal Then Intranasal Application', 'description': 'Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-22', 'studyFirstSubmitDate': '2015-03-02', 'resultsFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-22', 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Level of Tear Proteins Pre and Post Administration', 'timeFrame': 'Day 1'}, {'measure': 'Level of Inflammatory Mediators Pre and Post Administration', 'timeFrame': 'Day 1'}, {'measure': 'Goblet Cell Count Following Application', 'timeFrame': 'Day 1'}], 'primaryOutcomes': [{'measure': 'Fluorescein Tear Clearance With Application', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'referencesModule': {'references': [{'pmid': '28302532', 'type': 'DERIVED', 'citation': 'Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are:\n\n* To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications\n* To compare the goblet cell count following application between the intranasal and extranasal applications\n* To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications', 'detailedDescription': 'In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:\n\n* Active intranasal device application\n* Active extranasal device application'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral dry eyes\n* Capable of providing written informed consent\n\nExclusion Criteria:\n\n* Chronic or recurring epistaxis (nosebleeds)\n* Blood coagulation disorder\n* Uncontrolled or poorly controlled diabetes\n* Heart or pulmonary disease\n* Females who are pregnant, planning a pregnancy or nursing'}, 'identificationModule': {'nctId': 'NCT02385292', 'briefTitle': 'Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oculeve, Inc.'}, 'officialTitle': 'Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye', 'orgStudyIdInfo': {'id': 'OCUN-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal then Extranasal Application', 'description': 'Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.', 'interventionNames': ['Device: Oculeve Intranasal Lacrimal Neurostimulator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extranasal then Intranasal Application', 'description': 'Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.', 'interventionNames': ['Device: Oculeve Intranasal Lacrimal Neurostimulator']}], 'interventions': [{'name': 'Oculeve Intranasal Lacrimal Neurostimulator', 'type': 'DEVICE', 'description': "The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.", 'armGroupLabels': ['Extranasal then Intranasal Application', 'Intranasal then Extranasal Application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Grutzmacher, Lewis & Sierra', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine, Department of Ophthalmology', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Richard Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grutzmacher, Lewis & Sierra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oculeve, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}