Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-04-10 @ 12:14 AM
Study NCT ID:
NCT00575367
Status:
COMPLETED
Last Update Posted:
2011-09-22
First Post:
2007-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D015817', 'term': 'Eye Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kkuhn@inspirepharm.com', 'phone': '919 941-9777', 'title': 'Karen Kuhn/ Director', 'organization': 'Inspire Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'PI cannot publish or discuss trial results until written communication is received from Inspire Pharmaceuticals, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AzaSite', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vigamox', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AzaSite'}, {'id': 'OG001', 'title': 'Vigamox'}], 'classes': [{'title': '15 Minutes', 'categories': [{'measurements': [{'value': '16.485', 'spread': '22.9971', 'groupId': 'OG000'}, {'value': '8.199', 'spread': '15.9873', 'groupId': 'OG001'}]}]}, {'title': '1 Hour', 'categories': [{'measurements': [{'value': '4.007', 'spread': '4.3680', 'groupId': 'OG000'}, {'value': '2.221', 'spread': '4.1506', 'groupId': 'OG001'}]}]}, {'title': '2 Hours', 'categories': [{'measurements': [{'value': '1.966', 'spread': '3.6632', 'groupId': 'OG000'}, {'value': '2.985', 'spread': '5.6350', 'groupId': 'OG001'}]}]}, {'title': '4 Hours', 'categories': [{'measurements': [{'value': '1.558', 'spread': '2.6151', 'groupId': 'OG000'}, {'value': '0.603', 'spread': '1.0074', 'groupId': 'OG001'}]}]}, {'title': '8 Hours', 'categories': [{'measurements': [{'value': '2.590', 'spread': '4.8111', 'groupId': 'OG000'}, {'value': '1.364', 'spread': '2.7629', 'groupId': 'OG001'}]}]}, {'title': '24 Hours', 'categories': [{'measurements': [{'value': '0.195', 'spread': '0.2558', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.0449', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AzaSite'}, {'id': 'FG001', 'title': 'Vigamox'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AzaSite'}, {'id': 'BG001', 'title': 'Vigamox'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '12.59', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '13.29', 'groupId': 'BG001'}, {'value': '36.0', 'spread': '12.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures for two subjects were not included in this analysis due to missing data on too many data points. Although the total number of baseline participants was 37, the actual number included in the analysis was 35 subjects, 18 subjects in the Azasite group and 17 in the Vigamox group.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'lastUpdateSubmitDate': '2011-09-20', 'studyFirstSubmitDate': '2007-12-14', 'resultsFirstSubmitDate': '2009-08-10', 'studyFirstSubmitQcDate': '2007-12-14', 'lastUpdatePostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-11', 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.', 'timeFrame': '15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Infections', 'Eye Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.\n* Have normal lid anatomy.\n\nExclusion Criteria:\n\n* Have an abnormal biomicroscopy or ophthalmoscopy exam.\n* Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.\n* Have used artificial tears in the past thirty days.\n* Have a diagnosis of on-going ocular infection or lid margin inflammation.\n* Have ever had penetrating ocular surface or intraocular surgery.\n* Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.\n* Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.\n* Have had corneal or lid abnormalities.\n* Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.\n* Have any ocular pathology with the exception of cataracts.\n* Have a serious systemic disease or uncontrolled medical condition.\n* Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.\n* Have a history of liver or kidney disease resulting in persisting dysfunction.'}, 'identificationModule': {'nctId': 'NCT00575367', 'briefTitle': 'Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Tears of Healthy Volunteers Following a Single Ocular Administration', 'orgStudyIdInfo': {'id': '041-101'}, 'secondaryIdInfos': [{'id': 'P08653'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AzaSite', 'interventionNames': ['Drug: AzaSite (azithromycin ophthalmic solution)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vigamox', 'interventionNames': ['Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)']}], 'interventions': [{'name': 'AzaSite (azithromycin ophthalmic solution)', 'type': 'DRUG', 'description': 'One drop ophthalmic solution at Visit 2', 'armGroupLabels': ['AzaSite']}, {'name': 'Vigamox (moxifloxacin hydrochloride ophthalmic solution)', 'type': 'DRUG', 'description': 'One drop ophthalmic solution at Visit 2', 'armGroupLabels': ['Vigamox']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Reza Haque, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Karen Kuhn', 'oldOrganization': 'Inspire Pharmaceuticals, Inc.'}}}}