Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT05604651
Status:
COMPLETED
Last Update Posted:
2022-11-23
First Post:
2022-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'C536137', 'term': 'Medullary cystic kidney disease 1'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Conjunctival impression cytology samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-20', 'studyFirstSubmitDate': '2022-10-29', 'studyFirstSubmitQcDate': '2022-10-29', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mucin expression', 'timeFrame': 'immediately after meeting the inclusion and exclusion criteria', 'description': 'The mRNA expression of mucin was measured by Quantitative real-time PCR, which is a laboratory technique of molecular biology to find out how much of a specific section of DNA there is in a sample.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye Disease', 'Mucin'], 'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'The study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.', 'detailedDescription': 'The cross-sectional study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Video display terminals users with and without dry eye disease.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who exposed to video display terminals for more than 1 year (at least 5 days per week and 6 hours per day) were enrolled and divided into two groups: (1) VDT users with DED and (2) VDT users without DED. DED was diagnosed according to the Tear Film and Ocular Surface Society (TFOS) DEWS II criteria: (1) Ocular Surface Disease Index (OSDI) score ≥ 13 and (2) one of these signs; fluorescein tear breakup time (TBUT) \\<10 sec; abnormal ocular surface staining (\\>5 corneal spots or \\> 9 conjunctival spots).\n\nExclusion Criteria:\n\n* a history of contact lens wear or ocular surgery within 2 year of the study visit; a history of previous ocular disease; topical or systemic therapies other than artificial tears within two weeks before recruitment; and inflammatory ocular diseases, ocular surface diseases, glaucoma and systemic diseases with ocular involvement, such as meibomian gland dysfunction, diabetes, and peripheral neuropathy.'}, 'identificationModule': {'nctId': 'NCT05604651', 'briefTitle': 'Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease', 'orgStudyIdInfo': {'id': 'VDT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'dry eye disease', 'description': 'Dry eye disease was diagnosed according to the Tear Film and Ocular Surface Society (TFOS) DEWS II criteria: (1) Ocular Surface Disease Index (OSDI) score ≥ 13 and (2) one of these signs; fluorescein tear breakup time (TBUT) \\<10 sec; abnormal ocular surface staining (\\>5 corneal spots or \\> 9 conjunctival spots).', 'interventionNames': ['Other: no intervention']}, {'label': 'control', 'description': 'The controll group enrolled healthy participants without ocular and systemic diseases.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['control', 'dry eye disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Hong Qi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}