Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-04-08 @ 10:31 AM
Study NCT ID:
NCT00576251
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2007-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014031', 'term': 'Tobramycin'}, {'id': 'D000078162', 'term': 'Tobramycin, Dexamethasone Drug Combination'}], 'ancestors': [{'id': 'D009328', 'term': 'Nebramycin'}, {'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888.451.3937; 817.568.6725', 'title': 'Alcon Clinical', 'organization': 'Alcon Research, Ltd'}, 'certainAgreement': {'otherDetails': 'Sponsor is allowed 30 days to review publication. With reasonable justification, sponsor may require the publication to be withheld an additional 60 days to obtain patent protection. Sponsor may request deletion of any trade secret, proprietary, or confidential information.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tobramycin 0.3%/Dexamethasone 0.05%', 'description': 'Tobramycin 0.3%/Dexamethasone 0.05%', 'otherNumAtRisk': 109, 'otherNumAffected': 0, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TOBRADEX Ophthalmic Suspension', 'description': 'TOBRADEX Ophthalmic Suspension', 'otherNumAtRisk': 112, 'otherNumAffected': 0, 'seriousNumAtRisk': 112, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin 0.3%/Dexamethasone 0.05%', 'description': 'Tobramycin 0.3%/Dexamethasone 0.05%'}, {'id': 'OG001', 'title': 'TOBRADEX Ophthalmic Suspension', 'description': 'TOBRADEX Ophthalmic Suspension'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '94.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 4 - Test Of Cure (TOC) compared to Day 0', 'description': 'Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.', 'unitOfMeasure': 'Percent of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tobramycin 0.3%/Dexamethasone 0.05%', 'description': 'Tobramycin 0.3%/Dexamethasone 0.05%'}, {'id': 'FG001', 'title': 'TOBRADEX Ophthalmic Suspension', 'description': 'TOBRADEX Ophthalmic Suspension'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '20 enrolling sites (private ophthalmology clinical offices) with first subject enrolled 10/29/07 and last subject enrolled 2/14/08)', 'preAssignmentDetails': 'Parallel, 1:1 ratio; double-masked'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tobramycin 0.3%/Dexamethasone 0.05%', 'description': 'Tobramycin 0.3%/Dexamethasone 0.05%'}, {'id': 'BG001', 'title': 'TOBRADEX Ophthalmic Suspension', 'description': 'TOBRADEX Ophthalmic Suspension'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2008-03'}, 'lastUpdateSubmitDate': '2010-02-23', 'studyFirstSubmitDate': '2007-12-17', 'resultsFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-09', 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)', 'timeFrame': 'Day 4 - Test Of Cure (TOC) compared to Day 0', 'description': 'Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ocular inflammation', 'blepharaconjunctivitis'], 'conditions': ['Ocular Inflammation Associated With Blepharaconjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ocular inflammation associated with blepharaconjunctivitis\n\nExclusion Criteria:\n\n* ocular allergy\n* ocular disorders that would preclude safe administration of test article'}, 'identificationModule': {'nctId': 'NCT00576251', 'briefTitle': 'TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-07-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobramycin 0.3%/Dexamethasone 0.05%', 'description': 'Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes', 'interventionNames': ['Drug: Tobramycin 0.3%/Dexamethasone 0.05%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TOBRADEX', 'description': 'TOBRADEX 1 drop 4 times daily in both eyes', 'interventionNames': ['Drug: TOBRADEX']}], 'interventions': [{'name': 'Tobramycin 0.3%/Dexamethasone 0.05%', 'type': 'DRUG', 'description': 'Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days', 'armGroupLabels': ['Tobramycin 0.3%/Dexamethasone 0.05%']}, {'name': 'TOBRADEX', 'type': 'DRUG', 'description': 'TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days', 'armGroupLabels': ['TOBRADEX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Michael Brubaker, BSN MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Judy Vittitoe', 'oldOrganization': 'Alcon Research'}}}}