Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 1:20 AM
Study NCT ID:
NCT01156012
Status:
COMPLETED
Last Update Posted:
2015-01-22
First Post:
2010-06-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011453', 'term': 'Prostaglandins'}], 'ancestors': [{'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'p.pouliquen@laboratoires-thea.fr', 'phone': '33 473 981 436', 'title': 'Dr Pascale Pouliquen - Medical Director', 'organization': 'Laboratoires Théa'}, 'certainAgreement': {'otherDetails': 'All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'T2345', 'description': 'One drop of T2345\n\nT2345: One drop of T2345 at 9.00pm.', 'otherNumAtRisk': 213, 'otherNumAffected': 0, 'seriousNumAtRisk': 213, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Prostaglandin', 'description': 'One drop of prostaglandin\n\nProstaglandin: One drop of prostaglandin at 9.00pm', 'otherNumAtRisk': 189, 'otherNumAffected': 0, 'seriousNumAtRisk': 189, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 213, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T2345', 'description': 'One drop of T2345\n\nT2345: One drop of T2345 at 9.00pm.'}, {'id': 'OG001', 'title': 'Prostaglandin', 'description': 'One drop of prostaglandin\n\nProstaglandin: One drop of prostaglandin at 9.00pm'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.6', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 84', 'description': 'The worse eye is defined as:\n\n* If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye.\n* If only one eye is eligible this eye is the worse eye.\n* If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0.\n\nIf both eyes have the same IOP at D0 the worse eye is the right eye.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T2345', 'description': 'One drop of T2345\n\nT2345: One drop of T2345 at 9.00pm'}, {'id': 'FG001', 'title': 'Prostaglandin', 'description': 'One drop of prostaglandin\n\nProstaglandin: One drop of prostaglandin at 9.00pm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'use of commercial drug instead of study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non respect of one of inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Included patients= 404 patients but 2 patients without available data after Day 0. These 2 patients were excluded from the analyses sets.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T2345', 'description': 'One drop of T2345\n\nT2345: One drop of T2345 at 9.00pm.'}, {'id': 'BG001', 'title': 'Prostaglandin', 'description': 'One drop of prostaglandin\n\nProstaglandin: One drop of prostaglandin at 9.00pm'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '64.7', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Tunisia', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-09', 'studyFirstSubmitDate': '2010-06-30', 'resultsFirstSubmitDate': '2014-11-12', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-12', 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Intraocular Pressure (IOP)', 'timeFrame': 'Day 0 and Day 84', 'description': 'The worse eye is defined as:\n\n* If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye.\n* If only one eye is eligible this eye is the worse eye.\n* If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0.\n\nIf both eyes have the same IOP at D0 the worse eye is the right eye.'}]}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients diagnosed with glaucoma\n\nExclusion Criteria:\n\n* Under 18.'}, 'identificationModule': {'nctId': 'NCT01156012', 'briefTitle': 'Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'orgStudyIdInfo': {'id': 'LT2345-PIII-12/08'}, 'secondaryIdInfos': [{'id': '2009-011157-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T2345', 'description': 'One drop of T2345', 'interventionNames': ['Drug: T2345']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prostaglandin', 'description': 'One drop', 'interventionNames': ['Drug: Prostaglandin']}], 'interventions': [{'name': 'T2345', 'type': 'DRUG', 'description': 'One drop of T2345', 'armGroupLabels': ['T2345']}, {'name': 'Prostaglandin', 'type': 'DRUG', 'description': 'One drop', 'armGroupLabels': ['Prostaglandin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Medical Director', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}