Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT00521456
Status:
COMPLETED
Last Update Posted:
2009-10-01
First Post:
2007-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Sponsor:
Organization:
Raw JSON
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The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ketorolac Solution', 'otherNumAffected': 68, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle Solution', 'otherNumAffected': 57, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctival Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anterior chamber cell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anterior chamber flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resolution of Post Operative Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \\>50 cells)', 'unitOfMeasure': '% of participants with a score of 0', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Ocular Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Measured on a scale of 0-4 (0 = none, 4 = intolerable)', 'unitOfMeasure': '% of participants with a score of 0', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Mean Pupil Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '36.5', 'spread': '13.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Pupil area post-irrigation and aspiration', 'unitOfMeasure': 'millimeters squared (mm²)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'POST_HOC', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Change from baseline at Day 14', 'description': 'Patients with ≥ 3 line improvement in visual acuity', 'unitOfMeasure': 'Percentage of patients with ≥ 3 lines', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketorolac Solution'}, {'id': 'FG001', 'title': 'Vehicle Solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '28'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketorolac Solution'}, {'id': 'BG001', 'title': 'Vehicle Solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Between 45 and 65 years', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'dispFirstSubmitDate': '2009-09-29', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-29', 'studyFirstSubmitDate': '2007-08-23', 'dispFirstSubmitQcDate': '2009-09-29', 'resultsFirstSubmitDate': '2009-08-19', 'studyFirstSubmitQcDate': '2007-08-23', 'dispFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-09-29', 'studyFirstPostDateStruct': {'date': '2007-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of Post Operative Inflammation', 'timeFrame': 'Day 14', 'description': 'Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \\>50 cells)'}], 'secondaryOutcomes': [{'measure': 'Ocular Pain', 'timeFrame': 'Day 1', 'description': 'Measured on a scale of 0-4 (0 = none, 4 = intolerable)'}, {'measure': 'Mean Pupil Area', 'timeFrame': 'Day 0', 'description': 'Pupil area post-irrigation and aspiration'}]}, 'conditionsModule': {'conditions': ['Cataract Extraction']}, 'referencesModule': {'references': [{'pmid': '21145532', 'type': 'DERIVED', 'citation': 'Donnenfeld ED, Nichamin LD, Hardten DR, Raizman MB, Trattler W, Rajpal RK, Alpern LM, Felix C, Bradford RR, Villanueva L, Hollander DA, Schiffman RM. Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. doi: 10.1016/j.ajo.2010.09.003. Epub 2010 Dec 9.'}], 'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com/inquiries/trialsubject.aspx', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cataract surgery\n\nExclusion Criteria:\n\n* Uncontrolled ocular disease in cataract surgery eye'}, 'identificationModule': {'nctId': 'NCT00521456', 'briefTitle': 'A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '191578-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: ketorolac eye drops']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: ketorolac eye drops']}], 'interventions': [{'name': 'ketorolac eye drops', 'type': 'DRUG', 'description': '1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day\n\nPlacebo', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Allergan, Inc.'}}}}