Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00333918
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2006-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 522}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-13', 'studyFirstSubmitDate': '2006-06-04', 'studyFirstSubmitQcDate': '2006-06-05', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of ocular inflammation'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free'}]}, 'conditionsModule': {'keywords': ['Cataract Extraction', 'Anti-Inflammatory Agents, Non-Steroidal'], 'conditions': ['Pain', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery\n* Agree to return for all required visits\n* Agree to avoid disallowed medications\n\nExclusion Criteria:\n\n* Known hypersensitivity to bromfenac and salicylates'}, 'identificationModule': {'nctId': 'NCT00333918', 'briefTitle': 'Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery', 'orgStudyIdInfo': {'id': 'ISTA-BR-CS02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1-bromfenac ophthalmic solution', 'description': 'sterile ophthalmic solution', 'interventionNames': ['Drug: bromfenac ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2-placebo comparator', 'description': 'sterile ophthalmic solution', 'interventionNames': ['Drug: placebo comparator']}], 'interventions': [{'name': 'bromfenac ophthalmic solution', 'type': 'DRUG', 'armGroupLabels': ['1-bromfenac ophthalmic solution']}, {'name': 'placebo comparator', 'type': 'DRUG', 'armGroupLabels': ['2-placebo comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Ralph Bianca, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ISTA Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}