Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT01606735
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2012-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of IBI-10090 in Ocular Surgery Patients
Sponsor:
Organization:
Raw JSON
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None of the details, results, or other information for this study shall be published or made known to a third party without written consent from Icon Bioscience, Inc., except for disclosure to regulatory agencies if required by law.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '342 mcg', 'description': 'IBI-10090: dexamethasone', 'otherNumAtRisk': 58, 'otherNumAffected': 2, 'seriousNumAtRisk': 58, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': '517 mcg', 'description': 'IBI-10090: dexamethasone', 'otherNumAtRisk': 56, 'otherNumAffected': 2, 'seriousNumAtRisk': 56, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '697 mcg', 'description': 'IBI-10090: dexamethasone', 'otherNumAtRisk': 58, 'otherNumAffected': 1, 'seriousNumAtRisk': 58, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Corneal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Corneal endothelial cell loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Eye disorders'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '3.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anterior Chamber Cell Count at Day 8 Post-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '342 mcg', 'description': 'IBI-10090: dexamethasone'}, {'id': 'OG001', 'title': '517 mcg', 'description': 'IBI-10090: dexamethasone'}, {'id': 'OG002', 'title': '697 mcg', 'description': 'IBI-10090: dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '37.13', 'upperLimit': '62.87'}, {'value': '51.8', 'groupId': 'OG001', 'lowerLimit': '38.7', 'upperLimit': '64.87'}, {'value': '60.3', 'groupId': 'OG002', 'lowerLimit': '47.76', 'upperLimit': '72.93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 days post-treatment', 'description': 'This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.', 'unitOfMeasure': 'percentage of patients with ACC clearing', 'dispersionType': '95% Confidence Interval'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '342 mcg', 'description': 'IBI-10090: dexamethasone'}, {'id': 'FG001', 'title': '517 mcg', 'description': 'IBI-10090: dexamethasone'}, {'id': 'FG002', 'title': '697 mcg', 'description': 'IBI-10090: dexamethasone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '172', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '342 mcg', 'description': 'IBI-10090: dexamethasone'}, {'id': 'BG001', 'title': '517 mcg', 'description': 'IBI-10090: dexamethasone'}, {'id': 'BG002', 'title': '697 mcg', 'description': 'IBI-10090: dexamethasone'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '71.8', 'groupId': 'BG001'}, {'value': '70.1', 'spread': '10', 'groupId': 'BG002'}, {'value': '70.1', 'spread': '9.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '172', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2012-05-24', 'resultsFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2012-05-25', 'lastUpdatePostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-17', 'studyFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior Chamber Cell Count at Day 8 Post-Treatment', 'timeFrame': '8 days post-treatment', 'description': 'This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cataract surgery', 'ocular inflammation'], 'conditions': ['Inflammation Associated With Cataract Surgery']}, 'descriptionModule': {'briefSummary': 'This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for unilateral cataract surgery\n\nExclusion Criteria:\n\n* Ocular, topical, or oral corticosteroids within 7 days of Day 0'}, 'identificationModule': {'nctId': 'NCT01606735', 'briefTitle': 'Efficacy and Safety of IBI-10090 in Ocular Surgery Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ICON Bioscience Inc'}, 'officialTitle': 'A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery', 'orgStudyIdInfo': {'id': 'C11-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'interventionNames': ['Drug: IBI-10090']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'interventionNames': ['Drug: IBI-10090']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3', 'interventionNames': ['Drug: IBI-10090']}], 'interventions': [{'name': 'IBI-10090', 'type': 'DRUG', 'description': 'dexamethasone', 'armGroupLabels': ['Dose 1', 'Dose 2', 'Dose 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92545', 'city': 'Hemet', 'state': 'California', 'country': 'United States', 'facility': 'Inland Eye Specialists', 'geoPoint': {'lat': 33.74761, 'lon': -116.97307}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'California Eye Professionals', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}], 'overallOfficials': [{'name': 'Wendy Murahashi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ICON Bioscience Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}