Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 3:57 PM
Study NCT ID:
NCT01342094
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2011-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DE-111 Against Timolol Ophthalmic Solution 0.5%
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@santen.co.jp', 'phone': '+81-6-4802-9341', 'title': 'General Manager of Clinical Development Group', 'organization': 'Santen Pharmaceutical Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Week 0(Baseline) and Week 4(End of Study)', 'eventGroups': [{'id': 'EG000', 'title': 'DE-111', 'description': 'DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.', 'otherNumAtRisk': 82, 'otherNumAffected': 11, 'seriousNumAtRisk': 82, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Timolol', 'description': 'Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.', 'otherNumAtRisk': 84, 'otherNumAffected': 2, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J ver.14.1'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J ver.14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DE-111', 'description': 'DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-0.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0(Baseline) and Week 4(End of Study)', 'description': 'Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DE-111', 'description': 'DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.'}, {'id': 'FG001', 'title': 'Timolol', 'description': 'Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not meeting inclusion/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Prior to randomization all participants in the study were receiving Timolol ophthalmic solution 0.5% (one drop at a time, BID).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DE-111', 'description': 'DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.'}, {'id': 'BG001', 'title': 'Timolol', 'description': 'Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '62.4', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects who have instilled the investigational drug at least once.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'lastUpdateSubmitDate': '2015-06-14', 'studyFirstSubmitDate': '2011-04-24', 'resultsFirstSubmitDate': '2015-04-28', 'studyFirstSubmitQcDate': '2011-04-25', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-28', 'studyFirstPostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study', 'timeFrame': 'Week 0(Baseline) and Week 4(End of Study)', 'description': 'Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.'}]}, 'conditionsModule': {'keywords': ['Primary open angle glaucoma or ocular hypertension'], 'conditions': ['Open Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with primary open angle glaucoma or ocular hypertension\n* Provided signed, written informed consent\n* 20 years of age and older\n* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study\n\nExclusion Criteria:\n\n* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception\n* Presence of any abnormality or significant illness that could be expected to interfere with the study'}, 'identificationModule': {'nctId': 'NCT01342094', 'briefTitle': 'DE-111 Against Timolol Ophthalmic Solution 0.5%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -', 'orgStudyIdInfo': {'id': '01111005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DE-111 ophthalmic solution', 'description': 'DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.', 'interventionNames': ['Drug: DE-111 ophthalmic solution', 'Drug: Placebo ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol ophthalmic solution 0.5%', 'description': 'Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.', 'interventionNames': ['Drug: Timolol ophthalmic solution 0.5%', 'Drug: Placebo ophthalmic solution']}], 'interventions': [{'name': 'DE-111 ophthalmic solution', 'type': 'DRUG', 'armGroupLabels': ['DE-111 ophthalmic solution']}, {'name': 'Timolol ophthalmic solution 0.5%', 'type': 'DRUG', 'armGroupLabels': ['Timolol ophthalmic solution 0.5%']}, {'name': 'Placebo ophthalmic solution', 'type': 'DRUG', 'armGroupLabels': ['DE-111 ophthalmic solution', 'Timolol ophthalmic solution 0.5%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Santen study sites', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}