Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-01 @ 10:05 AM
Study NCT ID:
NCT02322528
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rick_barrett@urmc.rochester.edu', 'phone': '585-276-7439', 'title': 'Dr. James V. Aquavella', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Administration of 0.5% Lotemax', 'description': 'An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Surface Temperature of Both Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Administration of 0.5% Lotemax', 'description': 'An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '33.95', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '34.3', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'week 1', 'categories': [{'measurements': [{'value': '33.93', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'week 2', 'categories': [{'measurements': [{'value': '33.95', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 30 minutes, week 1, week 2', 'description': 'Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.', 'unitOfMeasure': 'degrees celcius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Administration of 0.5% Lotemax', 'description': 'An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'week 1', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'week 2', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 30 minutes, week 1, week 2', 'description': 'Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Administration of 0.5% Lotemax', 'description': 'An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Administration of Lotemax', 'description': 'An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '4.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2014-04-16', 'resultsFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-17', 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Temperature of Both Eyes', 'timeFrame': 'baseline, 30 minutes, week 1, week 2', 'description': 'Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.'}, {'measure': 'Visual Quality', 'timeFrame': 'baseline, 30 minutes, week 1, week 2', 'description': 'Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-invasive instruments', 'Environment', 'Wavefront', 'Placido Disk', 'Ellipsometer', 'Thermal Imaging'], 'conditions': ["Sjogren's Disease"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Age 50-70\n* Diagnosed with Sjogren's Disease\n* Good general health (defined by medication use that has not changed within the last 2 months and the absence of medical conditions that are deemed confounding to the data as determined by the PI)\n* Ability to give informed consent\n* Willing to spend time for the study; approximately one hour for a screening visit and between 60-90 minutes for each of the measurement visits\n* Either gender\n* Any racial or ethnic origin\n\nEXCLUSION CRITERIA:\n\n* Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).\n* Current acute eye disease that affects the surface of the eye such as, but not limited to blepharitis, ocular allergy, and infection.\n* Subjects who have had cataract surgery less than one year ago\n* Use of soft or hard contact lenses.\n* Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions).\n* Inability to provide analyzable data"}, 'identificationModule': {'nctId': 'NCT02322528', 'briefTitle': 'Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Evaluation of Ocular Surface Inflammatory Mediators and Ocular Surface Metrology Effected by Lotemax', 'orgStudyIdInfo': {'id': '47817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Administration of Lotemax', 'description': 'An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.', 'interventionNames': ['Drug: Administration of Lotemax']}], 'interventions': [{'name': 'Administration of Lotemax', 'type': 'DRUG', 'description': 'An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.', 'armGroupLabels': ['Administration of Lotemax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Flaum Eye Institute at the University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'James V Aquavella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'James V. Aquavella, MD', 'investigatorAffiliation': 'University of Rochester'}}}}