Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT02306668
Status:
UNKNOWN
Last Update Posted:
2014-12-03
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Surface Dry Eye Microbiome
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Conjunctival swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of bacteria or fungus from conjunctival swab', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dry eye'], 'conditions': ['Dry Eyes']}, 'descriptionModule': {'briefSummary': "The investigators seek to characterize the identity of all microorganisms residing on the eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a combination of analyses. Dry eye disease is thought to have an inflammatory basis and in the vast majority of cases the cause of the chronic inflammatory condition is unknown."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We will recruit 40 subjects from University of Washington Medicine Eye Institute with ocular surface discomfort consistent with dry eye syndrome, and 40 control subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dry eye syndrome with OSDI score greater than 60\n* control group with OSDI score less than 30\n\nExclusion Criteria:\n\n* recent history of contact lens wear\n* use of topical antibiotics or prescription eye medication in past 6 months\n* penetrating ocular surgery in the last 12 months\n* age less than 18 years'}, 'identificationModule': {'nctId': 'NCT02306668', 'briefTitle': 'Ocular Surface Dry Eye Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Microbiome Analysis of the Ocular Surface in Dry Eye Disease', 'orgStudyIdInfo': {'id': '46093-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ocular surface discomfort', 'description': 'There are no interventions with this observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sue Rath', 'role': 'CONTACT', 'email': 'raths@uw.edu'}, {'name': 'Russell Van Gelder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UW Medicine Eye Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Sue Rath, COT', 'role': 'CONTACT', 'email': 'raths@uw.edu', 'phone': '206-897-4331'}], 'overallOfficials': [{'name': 'Russell Van Gelder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW Medicine Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair, Department of Ophthalmology', 'investigatorFullName': 'Russell Van Gelder', 'investigatorAffiliation': 'University of Washington'}}}}