Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-03 @ 9:32 PM
Study NCT ID:
NCT02042820
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2014-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Surface Immune Response in Dry Eye Disease
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2014-01-17', 'studyFirstSubmitQcDate': '2014-01-20', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral Corneal Immune cell Status by IVCM', 'timeFrame': 'Visit 1', 'description': 'Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells'}, {'measure': 'Bulbar conjunctival immune cell Status by IVCM', 'timeFrame': 'Visit 1', 'description': 'Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells'}], 'secondaryOutcomes': [{'measure': 'Clinical Parameter: Ocular Surface Disease Index (OSDI)', 'timeFrame': 'Visit 1'}, {'measure': "Clinical Parameter: Schirmer's II test", 'timeFrame': 'Visit 1'}, {'measure': 'Clinical Parameter: Conjunctival staining with lissamine green', 'timeFrame': 'Visit 1'}, {'measure': 'Clinical Parameter: Corneal staining with fluorescein', 'timeFrame': 'Visit 1'}, {'measure': 'Clinical Parameter: Tear Break Up Time (TBUT)', 'timeFrame': 'Visit 1'}, {'measure': 'Clinical Parameter: Conjunctival redness', 'timeFrame': 'Visit 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye'], 'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an in vivo metric to measure inflammatory changes in the central cornea. The objective of the current study is to assess inflammatory response changes in the peripheral cornea and the conjunctiva by analyzing epithelial immune cell density and morphology in these areas and then correlating the IVCM findings to clinical signs and symptoms to establish novel objective imaging biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with and without Dry Eye Disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'For Dry Eye Disease Participants\n\nInclusion Criteria:\n\n* Age \\>18\n* Ability to consent to study\n* Symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity\n* Positive vital dye staining of the cornea\n* At least one of the following objective signs: (Schirmer I \\<10 mm at 5 minutes), decreased (\\<0.2 mm) tear meniscus, decreased tear breakup time (TBUT) of \\<10 seconds, positive vital dye staining of the conjunctiva\n\nFor Age-Match Controls\n\nInclusion Criteria:\n\n* Between the ages of 18-89\n* The ability to provide informed consent for study inclusion\n* Clear, healthy cornea\n* Normal tear meniscus (\\> 0.3 mm)\n\nFor Dry Eye Disease Participants\n\nExclusion Criteria:\n\n* History of contact lens wear in the past 3 months\n* History of ocular surgery in the past 6 months\n* Active ocular allergies\n* History of ocular infection in the past 3 months\n* History of diabetes\n* History of topical or systemic anti-inflammatory therapy in the past 1 month\n\nFor Age-Match Controls\n\nExclusion Criteria:\n\n* History of ocular or eyelid surgery within the past 12 months\n* History of herpetic or other infectious keratitis or other inflammatory eye disease\n* History of any other acute ocular disease\n* Current use of topical medications (not including artificial tears)\n* Current use of contact lenses\n* History of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy\n* History of cancer elsewhere in the body which is currently under systemic chemotherapy\n* Current glaucoma disease requiring use of glaucoma drops\n* History of Diabetes mellitus\n* Current diagnosis of dry eye disease'}, 'identificationModule': {'nctId': 'NCT02042820', 'briefTitle': 'Ocular Surface Immune Response in Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Ocular Surface Immune Response in Dry Eye Disease: Analysis of Conjunctival and Peripheral Corneal Immune Cell Alterations by In Vivo Confocal Microscopy and Clinical Correlation', 'orgStudyIdInfo': {'id': '13-149H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dry Eye Disease', 'description': "Confocal Imaging - In vivo confocal microscopy (IVCM)\n\nOphthalmic Examination:\n\n* Tear Break Up Time (TBUT)\n* Ocular Surface Disease Index (OSDI)\n* Schirmer's II test\n* Conjunctival staining with lissamine green\n* Corneal staining with fluorescein\n* Conjunctival redness assessment", 'interventionNames': ['Other: In vivo confocal microscopy (IVCM)']}, {'label': 'Control', 'description': "Confocal Imaging - In vivo confocal microscopy (IVCM)\n\nOphthalmic Examination:\n\n* TBUT\n* OSDI\n* Schirmer's II test\n* Conjunctival staining with lissamine green\n* Corneal staining with fluorescein\n* Conjunctival redness assessment", 'interventionNames': ['Other: In vivo confocal microscopy (IVCM)']}], 'interventions': [{'name': 'In vivo confocal microscopy (IVCM)', 'type': 'OTHER', 'description': 'IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.', 'armGroupLabels': ['Control', 'Dry Eye Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye and Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Pedram Hamrah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MEEI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}