Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-01 @ 12:27 PM
Study NCT ID:
NCT00347932
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2006-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C522124', 'term': 'besifloxacin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timothy.comstock@bausch.com', 'phone': '(585) 338-6631', 'title': 'Timothy Comstock', 'organization': 'Bausch & Lomb Incorporated'}, 'certainAgreement': {'otherDetails': 'Sponsor has 45 days to review materials and provide comments back to the investigator.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '8 days', 'description': 'Treatment emergent ocular adverse events occured in \\< 5% of the patients', 'eventGroups': [{'id': 'EG000', 'title': 'ISV-403', 'description': 'Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.', 'otherNumAtRisk': 741, 'otherNumAffected': 0, 'seriousNumAtRisk': 442, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.', 'otherNumAtRisk': 760, 'otherNumAffected': 0, 'seriousNumAtRisk': 432, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 432, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Resolution of Baseline Bacterial Conjunctivitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISV-403', 'description': 'Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5 +/- 1 day', 'description': 'The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat population, culture confirmed, as randomized'}, {'type': 'PRIMARY', 'title': 'Microbial Eradication of Baseline Bacterial Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISV-403', 'description': 'Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5 +/- 1 day', 'description': 'Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to treat population, culture confirmed, as randomized.'}, {'type': 'SECONDARY', 'title': 'Clinical Resolution of Baseline Bacterial Conjunctivitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISV-403', 'description': 'Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8 or 9', 'description': 'The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat population, culture confirmed, as randomized'}, {'type': 'SECONDARY', 'title': 'Microbial Eradication of Baseline Bacterial Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ISV-403', 'description': 'Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8 or 9', 'description': 'Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat population, culture confirmed, as randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ISV-403', 'description': 'Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'As Randomized population - received at least one dose of study medication', 'groupId': 'FG000', 'numSubjects': '475'}, {'comment': 'As Randomized Population - received at least one dose of study medication', 'groupId': 'FG001', 'numSubjects': '482'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}, {'groupId': 'FG001', 'numSubjects': '430'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'First subject enrolled 6/5/2006, last patient exited on 11/7/2007. This study was conducted at multiple sites in the US.', 'preAssignmentDetails': '957 Subjects with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or its vehicle, 11 subjects were discontinued due to failure to meet enrollment criteria or used disallowed medications.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ISV-403', 'description': 'Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<2 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': '2 to 19 years', 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}]}, {'title': '20 to 59 years', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '438', 'groupId': 'BG002'}]}]}, {'title': '>=60 years', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '602', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '312', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '624', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '475', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 957}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2006-06-30', 'resultsFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-12', 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Resolution of Baseline Bacterial Conjunctivitis', 'timeFrame': 'Day 5 +/- 1 day', 'description': 'The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection'}, {'measure': 'Microbial Eradication of Baseline Bacterial Infection', 'timeFrame': 'Day 5 +/- 1 day', 'description': 'Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.'}], 'secondaryOutcomes': [{'measure': 'Clinical Resolution of Baseline Bacterial Conjunctivitis', 'timeFrame': 'Day 8 or 9', 'description': 'The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection'}, {'measure': 'Microbial Eradication of Baseline Bacterial Infection', 'timeFrame': 'Day 8 or 9', 'description': 'Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Bacterial Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '32841261', 'type': 'DERIVED', 'citation': 'DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.'}, {'pmid': '20629472', 'type': 'DERIVED', 'citation': 'Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.'}, {'pmid': '19323612', 'type': 'DERIVED', 'citation': 'Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009 May;25(5):1159-69. doi: 10.1185/03007990902837919.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.\n* Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.\n\nExclusion Criteria:\n\n* Pregnant or nursing females.\n* Known hypersensitivity to fluoroquinolones or to any of the study ingredients.\n* Use of any antibiotic within 72 hours of treatment.\n* Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.\n* Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.'}, 'identificationModule': {'nctId': 'NCT00347932', 'briefTitle': 'A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.', 'orgStudyIdInfo': {'id': '433'}, 'secondaryIdInfos': [{'id': 'BOL-303224', 'type': 'REGISTRY', 'domain': 'CAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISV-403', 'description': '0.6% ISV-403 ophthalmic suspension', 'interventionNames': ['Drug: ISV-403']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle of ISV-403 ophthalmic suspension', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'ISV-403', 'type': 'DRUG', 'otherNames': ['besifloxacin', 'Besivance', 'BOL-303224'], 'description': 'Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.', 'armGroupLabels': ['ISV-403']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Laura Trusso', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}