Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-07 @ 7:56 PM
Study NCT ID:
NCT00621933
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2008-02-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surveillance of Ocular Surface Flora (SURFACE)
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President, Medical Affairs', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Serious adverse events and adverse events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'description': 'All patients receiving cataract surgery', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients receiving cataract surgery'}], 'classes': [{'title': 'Percentage of Species Oxacillin-Susceptible', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Percentage of Species Oxacillin-Resistant', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \\<= 0.25 ug/ml (susceptible) and \\>= 0.50 ug/ml (resistant).', 'unitOfMeasure': 'Percentage of Species', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. All patients with cultures performed of the ocular surface.'}, {'type': 'PRIMARY', 'title': 'Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients receiving cataract surgery'}], 'classes': [{'title': 'Percentage of Species Oxacillin-Susceptible', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Percentage of Species Oxacillin-Resistant', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \\<= 0.25 ug/ml (susceptible) and \\>= 0.50 ug/ml (resistant).', 'unitOfMeasure': 'Percentage of Species', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. All patients with cultures performed of the ocular surface.'}, {'type': 'SECONDARY', 'title': 'Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients receiving cataract surgery'}], 'classes': [{'title': 'Percentage of Species Oxacillin-Susceptible', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Percentage of Species Oxacillin-Resistant', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \\<= 2 ug/ml (susceptible) and \\>= 4 ug/ml (resistant).', 'unitOfMeasure': 'Percentage of Species', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. All patients with cultures performed of the ocular surface.'}, {'type': 'SECONDARY', 'title': 'Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients receiving cataract surgery'}], 'classes': [{'title': 'Percentage of Species Oxacillin-Susceptible', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Percentage of Species Oxacillin-Resistant', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \\<= 2 ug/ml (susceptible) and \\>= 4 ug/ml (resistant).', 'unitOfMeasure': 'Percentage of Species', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. All patients with cultures performed of the ocular surface.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients', 'description': 'All patients receiving cataract surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '399'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '399'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was a culture swab study at a single time-point. No medications were administered and patients were not followed beyond the initial culture.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'All patients receiving cataract surgery'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 50 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Between 50 and 59 years', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': 'Between 60 and 69 years', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}, {'title': 'Between 70 and 79 years', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}]}]}, {'title': 'Between 80 and 89 years', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Between 90 and 99 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '224', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '175', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Culture Swabs of the conjunctiva and eyelids'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2008-02-13', 'resultsFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-07-16', 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid', 'timeFrame': 'Baseline', 'description': 'Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \\<= 0.25 ug/ml (susceptible) and \\>= 0.50 ug/ml (resistant).'}, {'measure': 'Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva', 'timeFrame': 'Baseline', 'description': 'Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \\<= 0.25 ug/ml (susceptible) and \\>= 0.50 ug/ml (resistant).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid', 'timeFrame': 'Baseline', 'description': 'Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \\<= 2 ug/ml (susceptible) and \\>= 4 ug/ml (resistant).'}, {'measure': 'Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva', 'timeFrame': 'Baseline', 'description': 'Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \\<= 2 ug/ml (susceptible) and \\>= 4 ug/ml (resistant).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '21191448', 'type': 'BACKGROUND', 'citation': 'Olson R, Donnenfeld E, Bucci FA Jr, Price FW Jr, Raizman M, Solomon K, Devgan U, Trattler W, Dell S, Wallace RB, Callegan M, Brown H, McDonnell PJ, Conway T, Schiffman RM, Hollander DA. Methicillin resistance of Staphylococcus species among health care and nonhealth care workers undergoing cataract surgery. Clin Ophthalmol. 2010 Dec 10;4:1505-14. doi: 10.2147/OPTH.S14333.'}]}, 'descriptionModule': {'briefSummary': 'Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the treatment and prophylaxis of ocular infections. The present study is set to determine the bacteria present on the ocular surface in patients at the time of cataract surgery and to assess the rate of resistance of ocular isolates to commonly used topical antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cataract Surgery Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to undergo cataract surgery\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* NSAID in the eye to be swabbed within the past 30 days\n* Topical anesthetic, topical antibiotic or antiseptic, or dilating drops in the eye to the swabbed within the past 7 days\n* Over-the-counter artificial tear drops or astringent /redness reliever drops (e.g., Visine®, Clear eyes® in the eye to be swabbed on the day of trial\n* History of conjunctivitis or any ocular infection within the past 3 months'}, 'identificationModule': {'nctId': 'NCT00621933', 'briefTitle': 'Surveillance of Ocular Surface Flora (SURFACE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MA-Zymar-08-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Patients Receiving Cataract Surgery', 'description': 'All Patients Receiving Cataract Surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}