Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-26 @ 8:17 PM
Study NCT ID:
NCT00616993
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-29', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups.', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups.', 'timeFrame': 'Day 7'}]}, 'conditionsModule': {'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for unilateral ocular surgery.\n\nExclusion Criteria:\n\n* Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.'}, 'identificationModule': {'nctId': 'NCT00616993', 'briefTitle': 'Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sirion Therapeutics, Inc.'}, 'orgStudyIdInfo': {'id': 'ST-601-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Vehicle', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Difluprednate', 'interventionNames': ['Drug: Difluprednate']}], 'interventions': [{'name': 'Difluprednate', 'type': 'DRUG', 'description': 'Difluprednate', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Vehicle', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates of Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}], 'overallOfficials': [{'name': 'Roger Vogel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sirion Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sirion Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sirion Therapeutics', 'oldOrganization': 'Sirion Therapeutics'}}}}