Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT00704418
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2008-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053083', 'term': 'bromfenac'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tmcnamara@istavision.com', 'phone': '949-788-6000', 'title': 'Tim McNamara, Vice President, Clinical Research & Medical Affairs', 'organization': 'ISTA Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'The disclosure restriction on the PI is that the PI will provide to the sponsor a copy of proposed publication information for review, comment and approval following completion of the study and at least sixty (60) days prior to submission of the publication. If sponsor requests in writing, the PI will withhold publication until written permission is given by sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 days', 'eventGroups': [{'id': 'EG000', 'title': 'Bromfenac', 'description': 'Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily', 'otherNumAtRisk': 73, 'otherNumAffected': 6, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo, dosed 1 drop daily', 'otherNumAtRisk': 73, 'otherNumAffected': 19, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Corneal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Eye Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bromfenac', 'description': 'Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, dosed 1 drop daily'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\\>50 cells (intense)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward Analysis(LOCF), ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Are Pain Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bromfenac', 'description': 'Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, dosed 1 drop daily'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF Analysis, ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bromfenac', 'description': 'Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, dosed 1 drop daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Over-enrolled/surgery postponed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'This study was conducted at 19 sites, first participant entered the study 06/03/2008 and last participant completed the study 08/29/2008.', 'preAssignmentDetails': 'A total of 156 participants were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 78 were randomized to the bromfenac ophthalmic solution treatment group and 78 were randomized to the placebo treatment group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bromfenac', 'description': 'Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo, dosed 1 drop daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'groupId': 'BG000', 'lowerLimit': '27.0', 'upperLimit': '90.0'}, {'value': '68.0', 'groupId': 'BG001', 'lowerLimit': '43.0', 'upperLimit': '86.0'}, {'value': '68.4', 'groupId': 'BG002', 'lowerLimit': '27.0', 'upperLimit': '90.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', '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': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-11', 'studyFirstSubmitDate': '2008-06-20', 'resultsFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2008-06-20', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-07', 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero', 'timeFrame': 'Day 15', 'description': 'Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\\>50 cells (intense)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants That Are Pain Free', 'timeFrame': 'Day 1', 'description': 'Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract extraction', 'intraocular lens implantation'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '21751945', 'type': 'DERIVED', 'citation': 'Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for cataract surgery\n\nExclusion Criteria:\n\n* Known hypersensitivity to bromfenac and salicylates'}, 'identificationModule': {'nctId': 'NCT00704418', 'briefTitle': 'Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'orgStudyIdInfo': {'id': 'CL-S&E-0415081-P-WR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bromfenac', 'description': 'Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily', 'interventionNames': ['Drug: Bromfenac']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, dosed 1 drop daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bromfenac', 'type': 'DRUG', 'description': 'sterile ophthalmic solution', 'armGroupLabels': ['Bromfenac']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'sterile ophthalmic solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'ISTA Pharmaceuticals, Inc.', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}