Raw JSON
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'title': 'Travoprost Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '-1.5'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '0.7'}, {'value': '-2.7', 'groupId': 'OG002', 'lowerLimit': '-4.3', 'upperLimit': '-1.2'}, {'value': '-5.7', 'groupId': 'OG003', 'lowerLimit': '-7.5', 'upperLimit': '-3.9'}, {'value': '-4.8', 'groupId': 'OG004', 'lowerLimit': '-6.1', 'upperLimit': '-3.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 Days', 'description': 'Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TRAVATAN', 'description': 'TRAVATAN 0.004% once daily'}, {'id': 'FG001', 'title': 'Travoprost Vehicle', 'description': 'Travoprost Vehicle'}, {'id': 'FG002', 'title': 'Travoprost Group A', 'description': 'Travoprost Group A'}, {'id': 'FG003', 'title': 'Travoprost Group B', 'description': 'Travoprost Group B'}, {'id': 'FG004', 'title': 'Travoprost Group C', 'description': 'Travoprost Group C'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'TRAVATAN', 'description': 'TRAVATAN 0.004% once daily'}, {'id': 'BG001', 'title': 'Travoprost Vehicle', 'description': 'Travoprost Vehicle'}, {'id': 'BG002', 'title': 'Travoprost Group A', 'description': 'Travoprost Group A'}, {'id': 'BG003', 'title': 'Travoprost Group B', 'description': 'Travoprost Group B'}, {'id': 'BG004', 'title': 'Travoprost Group C', 'description': 'Travoprost Group C'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2011-05-26', 'studyFirstSubmitDate': '2010-04-30', 'resultsFirstSubmitDate': '2011-05-26', 'studyFirstSubmitQcDate': '2010-04-30', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-26', 'studyFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5', 'timeFrame': '5 days', 'description': 'Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment'}], 'secondaryOutcomes': [{'measure': 'IOP Change From Baseline at 8 PM on Day 5', 'timeFrame': '5 Days', 'description': 'Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Open-angle Glaucoma (OAG)', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. either sex and any race/ethnicity, ≥18 years old\n2. diagnosed with open-angle glaucoma, and/or ocular hypertension\n3. meets the following IOP entry criteria:\n\n * Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1\n * Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1\n4. satisfies all informed consent requirements; able to read, sign and date the informed consent\n\nExclusion Criteria:\n\n1. females of childbearing potential not meeting protocol conditions\n2. angle grade less than Grade 2 in either eye\n3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye\n4. severe central visual field loss in either eye\n5. any abnormality preventing reliable applanation tonometry in either eye\n6. hypersensitivity to prostaglandin analogues or to any component of the study medication'}, 'identificationModule': {'nctId': 'NCT01114893', 'briefTitle': 'Travoprost Five Day Posology Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-09-075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TRAVATAN', 'description': 'TRAVATAN 0.004% once daily', 'interventionNames': ['Drug: Travoprost 0.004%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Travoprost Vehicle', 'description': 'Travoprost Vehicle', 'interventionNames': ['Drug: Travoprost Vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'Travoprost Group A', 'description': 'Travoprost Group A', 'interventionNames': ['Drug: Travoprost (Groups A, B and C)']}, {'type': 'EXPERIMENTAL', 'label': 'Travoprost Group B', 'description': 'Travoprost Group B', 'interventionNames': ['Drug: Travoprost (Groups A, B and C)']}, {'type': 'EXPERIMENTAL', 'label': 'Travoprost Group C', 'description': 'Travoprost Group C', 'interventionNames': ['Drug: Travoprost (Groups A, B and C)']}], 'interventions': [{'name': 'Travoprost 0.004%', 'type': 'DRUG', 'description': '1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days', 'armGroupLabels': ['TRAVATAN']}, {'name': 'Travoprost Vehicle', 'type': 'DRUG', 'description': '1 drop in each eye 8 times daily for 5 days', 'armGroupLabels': ['Travoprost Vehicle']}, {'name': 'Travoprost (Groups A, B and C)', 'type': 'DRUG', 'description': '1 drop in each eye 8 times daily for 5 days', 'armGroupLabels': ['Travoprost Group A', 'Travoprost Group B', 'Travoprost Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center For Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Matt Walker, PhD', 'oldOrganization': 'Alcon Research, Ltd'}}}}