Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-28 @ 7:05 PM
Study NCT ID:
NCT01471093
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2011-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of OPC-12759 Ophthalmic Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CL_OPCJ_RDA_Team@otsuka.jp', 'phone': '+81-3-6361-7366', 'title': 'Director of Clinical Trials', 'organization': 'Otsuka Pharmaceutical Co., LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment period (2 days up to 15 days)', 'description': 'Safety analysis set consisted of all subjects who had received the investigational product at least once.\n\nWhite blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation.\n\nAdverse Events detected were systemic and not attributable to one specific intervention or another.', 'eventGroups': [{'id': 'EG000', 'title': 'OPC-12759 Solution', 'description': 'One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation).', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 6, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'OPC-12759 Suspension', 'description': 'One drop of OPC-12759 ophthalmic suspension was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation).', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 2, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 14.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Blurred Vision After Instillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-12759 Solution With Nasal Root Pressed/Not Pressed', 'description': 'One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.\n\nThe second instillation was conducted within 14 days after the first instillation.'}, {'id': 'OG001', 'title': 'OPC-12759 Suspension With Nasal Root Pressed/Not Pressed', 'description': 'One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.\n\nThe second instillation was conducted within 14 days after the first instillation.'}], 'classes': [{'title': 'With Nasal Root Press', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Without Nasal Root Press', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The first and second instillation', 'description': 'The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consisted of all subjects who had received the investigational product at least once.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Bitter Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-12759 Solution With Nasal Root Pressed/Not Pressed', 'description': 'One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.\n\nThe second instillation was conducted within 14 days after the first instillation.'}, {'id': 'OG001', 'title': 'OPC-12759 Suspension With Nasal Root Pressed/Not Pressed', 'description': 'One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.\n\nThe second instillation was conducted within 14 days after the first instillation.'}], 'classes': [{'title': 'With Nasal Root Press', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Without Nasal Root Press', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The first and second instillation', 'description': 'The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set consisted of all subjects who had received the investigational product at least once.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OPC-12759 Solution With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed', 'description': 'One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.\n\nThe second instillation was conducted within 14 days after the first instillation.'}, {'id': 'FG001', 'title': 'OPC-12759 Solution Without Nasal Root Pressed, Then OPC-12759 With Nasal Root Pressed', 'description': 'One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.\n\nThe second instillation was conducted within 14 days after the first instillation.'}, {'id': 'FG002', 'title': 'OPC-12759 Suspension With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed', 'description': 'One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.\n\nThe second instillation was conducted within 14 days after the first instillation.'}, {'id': 'FG003', 'title': 'OPC-12759 Suspension Without Nasal Root Pressed, Then OPC-12759 Solution With Nasal Root Pressed', 'description': 'One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.\n\nThe second instillation was conducted within 14 days after the first instillation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was a single-center, randomized, crossover, open-label study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OPC-12759 Solution', 'description': 'One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once.'}, {'id': 'BG001', 'title': 'OPC-12759 Suspension', 'description': 'One drop of OPC-12759 ophthalmic suspension was instilled into each eye once.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2011-11-03', 'resultsFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2011-11-09', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-03', 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Blurred Vision After Instillation', 'timeFrame': 'The first and second instillation', 'description': 'The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.'}, {'measure': 'Number of Subjects With Bitter Taste', 'timeFrame': 'The first and second instillation', 'description': 'The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI : {body weight (kg) / \\[height (m)\\] 2 } must be 17.6 or greater, and less than 26.4 kg/m2\n\nExclusion Criteria:\n\n1. Presence of ocular disorder\n2. Intraocular pressure of 21mmHg or higher\n3. Corrected visual acuity of less than 1.0\n4. Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow\n5. History of refractive surgery\n6. History of other ocular surgeries within 12 months\n7. Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose'}, 'identificationModule': {'nctId': 'NCT01471093', 'briefTitle': 'Safety Study of OPC-12759 Ophthalmic Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects', 'orgStudyIdInfo': {'id': '037E-11-004'}, 'secondaryIdInfos': [{'id': 'JapicCTI-111674', 'type': 'OTHER', 'domain': 'Japic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solution', 'description': 'A single dose of OPC-12759 Ophthalmic solution for two-day treatment', 'interventionNames': ['Drug: OPC-12759 Ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suspension', 'description': 'A single dose of OPC-12759 Ophthalmic suspension for two-day treatment', 'interventionNames': ['Drug: OPC-12759 Ophthalmic suspension']}], 'interventions': [{'name': 'OPC-12759 Ophthalmic solution', 'type': 'DRUG', 'description': '2％ OPC-12759 Ophthalmic solution', 'armGroupLabels': ['Solution']}, {'name': 'OPC-12759 Ophthalmic suspension', 'type': 'DRUG', 'description': '2％ OPC-12759 Ophthalmic suspension', 'armGroupLabels': ['Suspension']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'facility': 'Kansai region', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Eiji Murakami', 'role': 'STUDY_CHAIR', 'affiliation': 'Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}