Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT00699803
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2008-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of T-PRED(TM) Compared to Pred Forte(R)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009935', 'term': 'prednisolone acetate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susan.harris@bauschhealth.com', 'title': 'Study Director', 'organization': 'Bausch Health'}, 'certainAgreement': {'otherDetails': 'Contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 hours', 'eventGroups': [{'id': 'EG000', 'title': 'T-Pred', 'description': 'Tobramycin prednisolone acetate combination\n\nT-PRED: sterile ophthalmic solution at the first time point\n\nPred Forte: sterile ophthalmic solution at the first time point', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pred Forte', 'description': 'Prednisolone acetate\n\nT-PRED: sterile ophthalmic solution at the second time point\n\nPred Forte: sterile ophthalmic solution at the second time point', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Aqueous Humor Prednisolone Acetate Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T-Pred', 'description': 'Tobramycin prednisolone acetate combination\n\nT-PRED: sterile ophthalmic solution'}, {'id': 'OG001', 'title': 'Pred Forte', 'description': 'Prednisolone acetate\n\nT-PRED: sterile ophthalmic solution'}], 'classes': [{'categories': [{'measurements': [{'value': '102.5', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '127.5', 'spread': '66.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population was defined as all participants who received investigational product and on whom successful anterior chamber tap were performed at the designated time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T-Pred', 'description': 'Tobramycin prednisolone acetate combination\n\nT-PRED: sterile ophthalmic solution'}, {'id': 'FG001', 'title': 'Pred Forte', 'description': 'Prednisolone acetate\n\nPred Forte: sterile ophthalmic solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T-Pred', 'description': 'Tobramycin prednisolone acetate combination\n\nT-PRED: sterile ophthalmic solution'}, {'id': 'BG001', 'title': 'Pred Forte', 'description': 'Prednisolone acetate\n\nPred Forte: sterile ophthalmic solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '66.1', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2011-09-02', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2008-06-16', 'dispFirstSubmitQcDate': '2011-09-02', 'resultsFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2008-06-17', 'dispFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-18', 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Aqueous Humor Prednisolone Acetate Concentration', 'timeFrame': '4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'Study of T-PRED(TM) compared to Pred Forte(R)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n\nExclusion Criteria:\n\n* No active or adverse disease'}, 'identificationModule': {'nctId': 'NCT00699803', 'briefTitle': 'Study of T-PRED(TM) Compared to Pred Forte(R)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'orgStudyIdInfo': {'id': 'CL-PKT-0312081-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'T-Pred', 'description': 'Tobramycin prednisolone acetate combination', 'interventionNames': ['Drug: T-PRED']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pred Forte', 'description': 'Prednisolone acetate', 'interventionNames': ['Drug: Pred Forte']}], 'interventions': [{'name': 'T-PRED', 'type': 'DRUG', 'description': 'T-PRED sterile ophthalmic solution', 'armGroupLabels': ['T-Pred']}, {'name': 'Pred Forte', 'type': 'DRUG', 'description': 'Pred Forte sterile ophthalmic solution', 'armGroupLabels': ['Pred Forte']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'ISTA Pharmaceuticals, Inc.', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Tim McNamara, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ISTA Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}