Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-30 @ 3:44 AM
Study NCT ID:
NCT00430092
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2007-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C015808', 'term': 'difluprednate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbrace@siriontherapeutics.com', 'phone': '813-496-7325', 'title': 'Jeremy Brace', 'phoneExt': '343', 'organization': 'Sirion Therapeutics, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Difluprednate 0.05% BID', 'description': 'Difluprednate 0.05% 1 drop BID for 14 days'}, {'id': 'OG001', 'title': 'Difluprednate 0.05% QID', 'description': 'Difluprednate 0.05% 1 drop QID for 14 days'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.'}], 'classes': [{'title': 'Proportion of Subjects w/AC cell grade=0 on Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8 (QID)', 'description': 'Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \\> 50 cells.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Difluprednate 0.05% BID', 'description': 'Difluprednate 0.05% 1 drop BID for 14 days'}, {'id': 'FG001', 'title': 'Difluprednate 0.05% QID', 'description': 'Difluprednate 0.05% 1 drop QID for 14 days'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'First subject enrolled January 24, 2007 and last subject completed September 20, 2007 at 11 sites in the United States.', 'preAssignmentDetails': 'Subjects enrolled if, 24 hours after ocular surgery, they had an anterior chamber cell grade of ≥ "2" and met the protocol inclusion and exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Difluprednate 0.05% BID', 'description': 'Difluprednate 0.05% 1 drop BID for 14 days'}, {'id': 'BG001', 'title': 'Difluprednate 0.05% QID', 'description': 'Difluprednate 0.05% 1 drop QID for 14 days'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.7', 'spread': '0', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '0', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '0', 'groupId': 'BG002'}, {'value': '69.8', 'spread': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '129.0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '90.0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'lastUpdateSubmitDate': '2009-05-12', 'studyFirstSubmitDate': '2007-01-30', 'resultsFirstSubmitDate': '2009-05-12', 'studyFirstSubmitQcDate': '2007-01-31', 'lastUpdatePostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-12', 'studyFirstPostDateStruct': {'date': '2007-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).', 'timeFrame': 'Day 8 (QID)', 'description': 'Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \\> 50 cells.'}]}, 'conditionsModule': {'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '19101421', 'type': 'DERIVED', 'citation': 'Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009 Jan;35(1):26-34. doi: 10.1016/j.jcrs.2008.09.024.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral ocular surgery in the day prior to study enrollment.\n* Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1).\n* Aged 2 years or older on the day of consent.\n* Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator\'s discretion.\n* Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate.\n\nPresurgical Exclusion Criteria:\n\n* Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment.\n* Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug.\n* Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis.\n* Any history of glaucoma or ocular hypertension in the study eye.\n* History or presence of endogenous uveitis.\n* Any current corneal abrasion or ulceration.\n* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.\n* Allergy to similar drugs, such as other corticosteroids.\n* History of steroid-related IOP increase.\n* Scheduled surgery on the contralateral eye during the treatment period.\n* Unwilling to discontinue use of contact lenses during the study period.\n* Pregnancy or lactation.\n* Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.\n* Prior participation in the study described in this protocol.\n* Unable or unwilling to give signed informed consent prior to participation in any study related procedures.\n\nPostsurgical Exclusion Criteria:\n\n* Ocular hemorrhage which interferes with evaluation of postsurgery inflammation.\n* Injection of gas into the vitreous body during surgery.\n* Presence of IOP ≥24 mm Hg on Day 1 after surgery.'}, 'identificationModule': {'nctId': 'NCT00430092', 'briefTitle': 'Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sirion Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3 Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery', 'orgStudyIdInfo': {'id': 'ST-601A-002b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Difluprednate 0.05% BID', 'description': 'Difluprednate 0.05% 1 drop BID for 14 days', 'interventionNames': ['Drug: Difluprednate']}, {'type': 'EXPERIMENTAL', 'label': 'Difluprednate 0.05% QID', 'description': 'Difluprednate 0.05% 1 drop QID for 14 days', 'interventionNames': ['Drug: Difluprednate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Difluprednate', 'type': 'DRUG', 'armGroupLabels': ['Difluprednate 0.05% BID']}, {'name': 'Difluprednate', 'type': 'DRUG', 'armGroupLabels': ['Difluprednate 0.05% QID']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Comprehensive Eye Care', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}], 'overallOfficials': [{'name': 'Roger Vogel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sirion Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sirion Therapeutics, Inc.', 'class': 'INDUSTRY'}}}}