Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT05304650
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Usability Study of External Neuromodulation With iTEAR100 Generation 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open Label Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability', 'timeFrame': '30 days', 'description': 'Subjects rate the device usability similar to daily mobile applications and home devices using a scale from -3 to +3 with 0 being same as every day devices such as bank application, restaurant application, etc.'}], 'secondaryOutcomes': [{'measure': 'Symptom Scores', 'timeFrame': '30 days', 'description': 'OSDI and SPEED standard symptom scores'}, {'measure': 'Adverse Events', 'timeFrame': '30 days', 'description': 'Skin Damage, Headache, Dizziness, Sneezing'}, {'measure': 'Symptom Score', 'timeFrame': '30 Days', 'description': 'SPEED standard symptom score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment.', 'detailedDescription': 'A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment. Subjects sign a consent form and are sent a device. After downloading a mobile app, they can access the device and download a prescription. At 7 days, an official telehealth visit evaluates their success in the set up and training. At 30 days, the trial ends, A usability survey and symptom evaluation survey are used to determine success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Able to sign English language consent form and over age 18 and reside in the U.S.\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05304650', 'briefTitle': 'A Usability Study of External Neuromodulation With iTEAR100 Generation 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olympic Ophthalmics, Inc.'}, 'officialTitle': 'A Usability Study of External Neuromodulation With iTEAR100 Generation 2', 'orgStudyIdInfo': {'id': 'clp 010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'iTEAR100 Therapy', 'description': 'Treatment Arm. Assessment of usability of generation 2 connected devices', 'interventionNames': ['Device: iTEAR100']}], 'interventions': [{'name': 'iTEAR100', 'type': 'DEVICE', 'description': 'Controlled Stimulation External Nasal Nerve to stimulate tear production', 'armGroupLabels': ['iTEAR100 Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98027', 'city': 'Issaquah', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Gertner', 'role': 'CONTACT', 'email': 'mgertner@oo-med.com', 'phone': '650-283-9388'}], 'facility': 'Olympic Ophthalmics', 'geoPoint': {'lat': 47.5301, 'lon': -122.03262}}], 'centralContacts': [{'name': 'Michael Gertner', 'role': 'CONTACT', 'email': 'clinicaltrials@oo-med.com', 'phone': '650-300-9340'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olympic Ophthalmics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}