Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 10:44 PM
Study NCT ID:
NCT01010633
Status:
COMPLETED
Last Update Posted:
2012-01-09
First Post:
2009-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069559', 'term': 'Loteprednol Etabonate'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tuyen.ong@bausch.com', 'phone': '(973) 360-6389', 'title': 'Tuyen Ong, MD, MRCOphth', 'organization': 'Bausch & Lomb Incorporated'}, 'certainAgreement': {'otherDetails': 'All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Visit 3 post-operative day 1 thru visit 7 postoperative day 18', 'eventGroups': [{'id': 'EG000', 'title': 'Loteprednol', 'description': 'Loteprednol etabonate 0.5%', 'otherNumAtRisk': 203, 'otherNumAffected': 0, 'seriousNumAtRisk': 203, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'Vehicle of loteprednol etabonate', 'otherNumAtRisk': 203, 'otherNumAffected': 0, 'seriousNumAtRisk': 203, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Cystoid Macular Edema', 'notes': 'Unrelated to study drug, but probably related to study procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'notes': 'The event is serious, unexpected, unrelated to the study drug and the study procedure but rather possibly related to a concomitant illness in a predisposed patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Heart Failure', 'notes': 'SAEs were unrelated to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resolution of Anterior Chamber Cells (ACC).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol', 'description': 'Loteprednol Etabonate 0.5%'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle of Loteprednol Etabonate'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '5.7', 'ciUpperLimit': '22.9', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 5 (Postoperative day 8)', 'description': 'Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Resolution of Anterior Chamber Cells.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol', 'description': 'Loteprednol Etabonate 0.5%'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle of Loteprednol Etabonate'}], 'classes': [{'title': 'Visit 4', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At visits 4-7- postoperative day 3, 8,15 & 18', 'description': 'Study eyes with complete resolution of anterior chamber cells (ACC)', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Grade 0 Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol', 'description': 'Loteprednol Etabonate 0.5%'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle of Loteprednol Etabonate'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.0', 'ciLowerLimit': '21.4', 'ciUpperLimit': '40.7', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 5 (Postoperative Day 8)', 'description': 'Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Intent to treat population (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Loteprednol', 'description': 'Loteprednol etabonate 0.5%'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Vehicle of loteprednol etabonate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.', 'preAssignmentDetails': '406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Loteprednol', 'description': 'Loteprednol etabonate 0.5%'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Vehicle of loteprednol etabonate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.3', 'spread': '8.73', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '9.80', 'groupId': 'BG001'}, {'value': '69.1', 'spread': '9.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-08', 'studyFirstSubmitDate': '2009-11-06', 'resultsFirstSubmitDate': '2011-08-30', 'studyFirstSubmitQcDate': '2009-11-09', 'lastUpdatePostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-08', 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of Anterior Chamber Cells (ACC).', 'timeFrame': 'Visit 5 (Postoperative day 8)', 'description': 'Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.'}, {'measure': 'Grade 0 Pain', 'timeFrame': 'Visit 5 (Postoperative Day 8)', 'description': 'Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.'}], 'secondaryOutcomes': [{'measure': 'Resolution of Anterior Chamber Cells.', 'timeFrame': 'At visits 4-7- postoperative day 3, 8,15 & 18', 'description': 'Study eyes with complete resolution of anterior chamber cells (ACC)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Pain']}, 'referencesModule': {'references': [{'pmid': '24136301', 'type': 'DERIVED', 'citation': 'Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who are at least 18 years of age.\n* Subjects who are candidates for routine, uncomplicated cataract surgery.\n* Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.\n\nExclusion Criteria:\n\n* Subjects who have known hypersensitivity or contraindication to the study drug or components.\n* Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.\n* Subjects with elevated intraocular pressure (\\>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.\n* Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye."}, 'identificationModule': {'nctId': 'NCT01010633', 'briefTitle': 'Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'orgStudyIdInfo': {'id': '576'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Loteprednol Etabonate', 'description': 'Loteprednol etabonate', 'interventionNames': ['Drug: Loteprednol Etabonate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle of loteprednol etabonate', 'interventionNames': ['Drug: Vehicle of Loteprednol Etabonate']}], 'interventions': [{'name': 'Vehicle of Loteprednol Etabonate', 'type': 'DRUG', 'description': '1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.', 'armGroupLabels': ['Vehicle']}, {'name': 'Loteprednol Etabonate', 'type': 'DRUG', 'description': '1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.', 'armGroupLabels': ['Loteprednol Etabonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Laura Trusso', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}