Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-01 @ 4:29 AM
Study NCT ID:
NCT00105534
Status:
COMPLETED
Last Update Posted:
2013-11-21
First Post:
2005-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
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'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': 333, 'otherNumAffected': 0, 'seriousNumAtRisk': 333, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle', 'otherNumAtRisk': 350, 'otherNumAffected': 0, 'seriousNumAtRisk': 350, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Cornela Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (7.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Who Achieved Clinical Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AzaSite'}, {'id': 'OG001', 'title': 'Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3 (Days 6-7)', '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 participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Bacteriological Eradication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AzaSite'}, {'id': 'OG001', 'title': 'Vehicle'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3 (Day 6-7)', 'description': 'Bacterial eradication is defined as the 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 participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AzaSite'}, {'id': 'FG001', 'title': 'Vehicle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '335'}, {'groupId': 'FG001', 'numSubjects': '350'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '313'}, {'groupId': 'FG001', 'numSubjects': '317'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Treatment unmasked', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AzaSite', 'description': 'Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'spread': '24.49', 'groupId': 'BG000'}, {'value': '30.8', 'spread': '28.07', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '26.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 685}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2005-03-15', 'resultsFirstSubmitDate': '2011-08-01', 'studyFirstSubmitQcDate': '2005-03-15', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-20', 'studyFirstPostDateStruct': {'date': '2005-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Who Achieved Clinical Resolution', 'timeFrame': 'Visit 3 (Days 6-7)', 'description': 'Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.'}], 'secondaryOutcomes': [{'measure': 'Participants Who Achieved Bacteriological Eradication', 'timeFrame': 'Visit 3 (Day 6-7)', 'description': 'Bacterial eradication is defined as the 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', 'Eye Discharge'], 'conditions': ['Bacterial Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '18374301', 'type': 'DERIVED', 'citation': 'Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM; AzaSite Clinical Study Group. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008 Jun;145(6):959-65. doi: 10.1016/j.ajo.2008.01.019. Epub 2008 Mar 28.'}], '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 vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', '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, 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 the 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': 'NCT00105534', 'briefTitle': 'Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)', '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 Vehicle in the Treatment of Bacterial Conjunctivitis', 'orgStudyIdInfo': {'id': 'P08635'}, 'secondaryIdInfos': [{'id': 'C-01-401-003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AzaSite', 'interventionNames': ['Drug: AzaSite']}, {'type': 'SHAM_COMPARATOR', 'label': 'Vehicle', 'interventionNames': ['Other: Vehicle']}], 'interventions': [{'name': 'AzaSite', 'type': 'DRUG', 'description': '1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected\n\neye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.', 'armGroupLabels': ['AzaSite']}, {'name': 'Vehicle', 'type': 'OTHER', 'description': 'Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86001', 'city': 'Flagstaff', 'state': 'Arizona', 'country': 'United States', 'facility': 'I Care! Eye Care!', 'geoPoint': {'lat': 35.19807, 'lon': -111.65127}}, {'zip': '90201', 'city': 'Cudahy', 'state': 'California', 'country': 'United States', 'facility': 'Rx For Life, Inc.', 'geoPoint': {'lat': 33.96057, 'lon': -118.18535}}, {'zip': '95401', 'city': 'Petaluma and Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'North Bay Eye Associates'}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Eye and Laser Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western States Clinical Research', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Opticare Eye Health Center', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'International Eye Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Welborn Clinic and Welborn Clinic East', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Taustine Eye Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Bossier Optical Inc.', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '70506', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Bohn and Joseph Eye Center', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '70791', 'city': 'Zachary', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The Louisiana Eye Center', 'geoPoint': {'lat': 30.64852, 'lon': -91.1565}}, {'zip': '39564', 'city': 'Ocean Springs', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Mississippi Eye Associates', 'geoPoint': {'lat': 30.41131, 'lon': -88.82781}}, {'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Research Laboratories', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}, {'zip': '08078', 'city': 'Runnemede', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Advanced Eyecare and Laser Center', 'geoPoint': {'lat': 39.85234, 'lon': -75.06795}}, {'zip': '11743', 'city': 'Huntington', 'state': 'New York', 'country': 'United States', 'facility': 'Precision Eye Care', 'geoPoint': {'lat': 40.86815, 'lon': -73.42568}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye, Ear, Nose, and Throat', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Horizon Eye Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Groat Eyecare Associates', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '44115', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Abrams Eye Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'Bend Memorial Clinic', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '37803', 'city': 'Maryville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University Eye Surgeons', 'geoPoint': {'lat': 35.75647, 'lon': -83.97046}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care, PA', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Eye Associates', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78704', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Metaclin Research, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77002', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Physicians Eye Associates & Cosmetic Laser', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Marc Sanders, MD', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77504', 'city': 'Pasadena', 'state': 'Texas', 'country': 'United States', 'facility': 'Mark Mayo, MD', 'geoPoint': {'lat': 29.69106, 'lon': -95.2091}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sun Research Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Mountain View Eye Center', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Cottonwood Eye and Laser Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53209', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Advanced Healthcare, SC', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}