Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-31 @ 11:55 AM
Study NCT ID:
NCT00520260
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2007-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-04-09', 'releaseDate': '2012-03-14'}, {'resetDate': '2012-05-15', 'releaseDate': '2012-04-18'}], 'estimatedResultsFirstSubmitDate': '2012-03-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053083', 'term': 'bromfenac'}, {'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2007-08-21', 'studyFirstSubmitQcDate': '2007-08-22', 'lastUpdatePostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular comfort', 'timeFrame': 'six weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dry Eye Disease', 'Ocular Comfort']}, 'descriptionModule': {'briefSummary': 'To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be in general good health\n* Diagnosis of moderate to severe dry eye syndrome\n\nExclusion Criteria:\n\n* Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy\n* Patients who are pregnant or nursing females\n* Unwilling to discontinue use of contact lenses during the run-in and duration of the study\n* Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye\n* Previous treatment failure on CSA 0.05% (Restasis)\n* Known hypersensitivity to any component of the study or procedural medications\n* Participation in any other clinical trial within 30 days prior to screening\n* Known contraindication to any study medication or any of their components.\n* Should not be taking any oral anti-histamines, beta blockers or diuretics.'}, 'identificationModule': {'nctId': 'NCT00520260', 'briefTitle': 'Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase', 'organization': {'class': 'OTHER', 'fullName': 'Florida Eye Microsurgical Institute'}, 'officialTitle': 'Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients', 'orgStudyIdInfo': {'id': 'Sch012007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Active treatment arm bromfenac 0.09% BID for 6 weeks', 'interventionNames': ['Drug: bromfenac']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'ketorolac 0.4% BID for 6 weeks', 'interventionNames': ['Drug: ketorolac']}], 'interventions': [{'name': 'bromfenac', 'type': 'DRUG', 'description': '0.09%, BID, 6 weeks', 'armGroupLabels': ['1']}, {'name': 'ketorolac', 'type': 'DRUG', 'description': '0.4%, BID, 6 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Eye Microsurgical Institute', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}], 'overallOfficials': [{'name': 'Barry Schechter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Eye Microsurgical Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Eye Microsurgical Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Barry Schechter, MD', 'oldOrganization': 'Florida Eye Microsurgical Institute'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-03-14', 'type': 'RELEASE'}, {'date': '2012-04-09', 'type': 'RESET'}, {'date': '2012-04-18', 'type': 'RELEASE'}, {'date': '2012-05-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Florida Eye Microsurgical Institute'}}}}