Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-01-25 @ 10:42 AM
Study NCT ID:
NCT04763018
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2021-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sham device produces noise but no stimulation energy. Assessor does not know which device the subject received. The subject does not know which device he or she received'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Day 14-30, all subjects receive therapy device'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2021-02-14', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meibomian Gland change in expressibility', 'timeFrame': '14 days', 'description': 'Change in gland expression from meibomian glands'}, {'measure': 'Corneal Staining', 'timeFrame': '14 days', 'description': 'Change in Staining of cornea'}, {'measure': 'Basal tear output', 'timeFrame': '14 days', 'description': 'Change in the basal output of tears'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '30 days', 'description': 'Incidence of Events which prevent device usage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Visual Display Users With Previously Undiagnosed Dry Eye']}, 'descriptionModule': {'briefSummary': 'Two study arms - sham and treatment; There will be a cross over of the sham group to the treatment group at day 15.', 'detailedDescription': 'This is a post market study. The active device will be the FDA cleared device used within its labeling. The sham group will receive an iTEAR device which looks identical to and makes noise similar to a fully functional iTEAR device but has a tip that does not vibrate. All subjects in the sham group will crossover to the treatment group after 2 two weeks and all patients will continue to 30 days.\n\nThe study will be conducted at up to 5 sites in the United States. It will enroll 30 subjects for 30 days.\n\nThis is a double-masked study with 10 subjects receiving sham and 20 subjects receiving treatment. The subjects and the examining investigators are masked to treatment until the crossover.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 6hrs visual display terminal\n* OSDI \\> 13\n* One of: SChirmer \\< 10, One quadrant staining \\> 2, or Meibomian Gland expression \\<12\n\nExclusion Criteria:\n\n* Opinion of investigator that subject not be in the study'}, 'identificationModule': {'nctId': 'NCT04763018', 'briefTitle': 'Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olympic Ophthalmics, Inc.'}, 'officialTitle': 'A Randomized Sham Controlled Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users', 'orgStudyIdInfo': {'id': 'CLP-OO8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'This arm will receive a function iTEAR', 'interventionNames': ['Device: iTEAR100']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'This arm will receive sham treatment device', 'interventionNames': ['Device: iTEAR100']}], 'interventions': [{'name': 'iTEAR100', 'type': 'DEVICE', 'description': 'Neurostimulation external nasal nerve to stimulate tear production', 'armGroupLabels': ['Sham', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fishman Vision', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Michael gertner, MD', 'role': 'CONTACT', 'email': 'mgertner@oo-med.com', 'phone': '650-283-9388'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'December 2021', 'ipdSharing': 'YES', 'description': 'All results will be shared at conclusion of last follow up visit'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olympic Ophthalmics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}