Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-27 @ 10:15 PM
Study NCT ID:
NCT00854061
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2009-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of T-PRED(TM) Compared to Pred Forte(R) II
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': '35 days', 'description': 'The safety population was comprised of participants who received study treatment and had at least one post-baseline safety assessment. Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.g', 'eventGroups': [{'id': 'EG000', 'title': 'T-Pred', 'otherNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Pred-Forte', 'otherNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'IOL dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 2.0'}, {'term': 'Vitritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 2.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Means Aqueous Humor Prednisolone Acetate Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', '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\nPred Forte: sterile ophthalmic solution'}], 'classes': [{'categories': [{'measurements': [{'value': '100.02', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '131.65', 'spread': '9.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35 days', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Participants received both treatment groups, one in each eye.\n\nA total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.\n\nThe investigator determined which eye was clinically suited for the first operative procedure (surgery); treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}]}, {'type': 'Completed 1st Surgery (T-PRED in One Eye and Pred Forte in the Other Eye)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': 'Completed 2nd Surgery (T-PRED and Pred Forte in Opposite Eyes Compared to 1st Surgery)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2011-09-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2009-02-26', 'dispFirstSubmitQcDate': '2011-09-02', 'resultsFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2009-02-26', 'dispFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-16', 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Means Aqueous Humor Prednisolone Acetate Concentration', 'timeFrame': '35 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'Study of T-PRED(TM) Compared to Pred Forte(R)', 'detailedDescription': 'This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.\n\nThe investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n\nExclusion Criteria:\n\n* No active or adverse disease'}, 'identificationModule': {'nctId': 'NCT00854061', 'briefTitle': 'Study of T-PRED(TM) Compared to Pred Forte(R) II', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'orgStudyIdInfo': {'id': 'CL-PKT-0415083-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', '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': 'sterile ophthalmic solution', 'armGroupLabels': ['T-Pred']}, {'name': 'Pred Forte', 'type': 'DRUG', 'description': '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'}}}}