Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT00105469
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2005-03-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003234', 'term': 'Conjunctivitis, Bacterial'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D015817', 'term': 'Eye Infections'}], 'ancestors': [{'id': 'D015818', 'term': 'Eye Infections, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D014031', 'term': 'Tobramycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009328', 'term': 'Nebramycin'}, {'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Vice President, Late Stage Development Group Leader', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Institution and Principal Investigator shall not publish, present or use any data or results arising out of the performance of this study for their own instruction, research or publication without the prior express written consent of Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AzaSite', 'otherNumAtRisk': 365, 'otherNumAffected': 0, 'seriousNumAtRisk': 365, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tobramycin', 'otherNumAtRisk': 378, 'otherNumAffected': 0, 'seriousNumAtRisk': 378, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved Clinical Resolution at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AzaSite'}, {'id': 'OG001', 'title': 'Tobramycin'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3 (Day 6)', 'description': 'Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population (defined as all randomized\n\nsubjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of\n\npathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Bacterial Eradication at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AzaSite'}, {'id': 'OG001', 'title': 'Tobramycin'}], 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3 (Day 6)', 'description': 'Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population (defined as all randomized\n\nsubjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of\n\npathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AzaSite'}, {'id': 'FG001', 'title': 'Tobramycin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '378'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '343'}, {'groupId': 'FG001', 'numSubjects': '367'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AzaSite', 'description': 'Per protocol population (defined as all randomized\n\nsubjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of\n\npathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.'}, {'id': 'BG001', 'title': 'Tobramycin', 'description': 'Per protocol population (defined as all randomized\n\nsubjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of\n\npathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '20.23', 'groupId': 'BG000'}, {'value': '22.8', 'spread': '22.61', 'groupId': 'BG001'}, {'value': '20.4', 'spread': '21.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 743}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2005-03-14', 'resultsFirstSubmitDate': '2011-08-01', 'studyFirstSubmitQcDate': '2005-03-14', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-20', 'studyFirstPostDateStruct': {'date': '2005-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Achieved Clinical Resolution at Visit 3', 'timeFrame': 'Visit 3 (Day 6)', 'description': 'Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Achieved Bacterial Eradication at Visit 3', 'timeFrame': 'Visit 3 (Day 6)', 'description': 'Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bacterial Conjunctivitis', 'Pink Eye', 'Conjunctivitis', 'Eye Infection'], 'conditions': ['Bacterial Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '17652708', 'type': 'DERIVED', 'citation': 'Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413.'}], 'seeAlsoLinks': [{'url': 'http://www.insitevision.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject, of any race, who is at least 1 year of age.\n* Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.\n* The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.\n* Must be willing to discontinue contact lens wear for the duration of the study.\n\nExclusion Criteria:\n\n* Any uncontrolled systemic disease or debilitating disease.\n* Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.\n* Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study.\n* Any active upper respiratory tract infection.\n* Pregnant or nursing females.\n* Use of any antibiotic (topical or systemic) within 72 hours of enrollment.'}, 'identificationModule': {'nctId': 'NCT00105469', 'briefTitle': 'Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis', 'orgStudyIdInfo': {'id': 'P08633'}, 'secondaryIdInfos': [{'id': 'C-01-401-004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AzaSite', 'description': '1.0% azithromycin in DuraSite', 'interventionNames': ['Drug: AzaSite']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobramycin', 'description': '0.3% tobramycin', 'interventionNames': ['Drug: Tobramycin']}], 'interventions': [{'name': 'AzaSite', 'type': 'DRUG', 'description': 'AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.', 'armGroupLabels': ['AzaSite']}, {'name': 'Tobramycin', 'type': 'DRUG', 'description': 'Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.', 'armGroupLabels': ['Tobramycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Renaissance Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80122', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Eye Physicians", 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Eye Associates', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'The Eye Associates', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Alan Shuster, MD', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasco Eye Institute', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '33169', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Tukoi Institute for Clinical Research', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Eye Care', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Presidential Eye Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Jon Fishburn, MD', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Medisphere Medical Research Center, LLC', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '67502', 'city': 'Hutchinson', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hutchinson Clinic', 'geoPoint': {'lat': 38.06084, 'lon': -97.92977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye and Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mason Eye Institute', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Eye Care Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '11746', 'city': 'Huntington Station', 'state': 'New York', 'country': 'United States', 'facility': 'Huntington Medical Group', 'geoPoint': {'lat': 40.85343, 'lon': -73.41151}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cornerstone Eye Care', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '97209', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Eye Health Northwest', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15228', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Irving Weinberger, MD', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Southern Eye Associates, PA', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '79904', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Corona Research Consultants, Inc.', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Cottonwood Ophthalmology Associates', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '99205', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Rockwood Clinic, PS-Eye Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'Wenatchee Valley Medical Center', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vice President, Late Stage Development Group Leader', 'oldOrganization': 'Merck Sharp & Dohme Corp'}}}}