Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 4:07 AM
Study NCT ID:
NCT01244334
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2010-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-10-08', 'releaseDate': '2013-07-29'}, {'resetDate': '2014-08-25', 'releaseDate': '2014-08-11'}], 'estimatedResultsFirstSubmitDate': '2013-07-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D015715', 'term': 'Corneal Edema'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C015808', 'term': 'difluprednate'}, {'id': 'C009935', 'term': 'prednisolone acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-06', 'studyFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30', 'timeFrame': 'change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 30'}], 'primaryOutcomes': [{'measure': 'Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1', 'timeFrame': 'Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1'}], 'secondaryOutcomes': [{'measure': 'Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15', 'timeFrame': 'change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cataract surgery, vision, corneal edema, retinal thickness'], 'conditions': ['Cataracts', 'Corneal Edema', 'Retinal Structural Change, Deposit and Degeneration', 'Visual Acuity Reduced Transiently']}, 'referencesModule': {'references': [{'pmid': '21704965', 'type': 'DERIVED', 'citation': 'Donnenfeld ED, Holland EJ, Solomon KD, Fiore J, Gobbo A, Prince J, Sandoval HP, Shull ER, Perry HD. A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. Am J Ophthalmol. 2011 Oct;152(4):609-617.e1. doi: 10.1016/j.ajo.2011.03.018. Epub 2011 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female 21 years of age or older\n* Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries.\n* Willing and able to administer eye drops and record the times the drops were instilled\n* Understand and are willing to sign the Informed Consent form\n* Willing to complete the entire course of the study.\n\nExclusion Criteria:\n\n* Use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery.\n* Known sensitivity to any of the ingredients in the study medications or similar medications.\n* Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart.\n* Corneal edema in either eye.\n* Need for regional or general anesthesia during surgery.\n* Complicated cataract surgery, including use of iris hooks or iris stretchers.\n* Sight better than 20/100 in only one eye.\n* A history of previous intraocular surgery in either eye.\n* A history of uveitis, iritis, or intraocular inflammation.\n* Macular pathology of the retina.\n* Presence of glaucoma.\n* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.\n* History of steroid-related intraocular pressure (IOP) rise in the study eye.\n* Lack of an intact corneal epithelium.\n* Pupils that do not dilate to more than 5 mm prior to surgery or you require mechanical stretching of your pupil.\n* Diabetes mellitus.\n* Required use of a systemic steroidal or non-steroidal anti-inflammatory during the study period.\n* Doctor has determined the presence of a condition (i.e., UNCONTROLLED systemic disease) or a situation that may put the subject at significant risk, confound the study results or may interfere significantly with your participation in the study.\n* Females, who are pregnant, nursing an infant or planning a pregnancy.\n* Currently involved in another investigational study or have participated in one within the 30 days prior to entering this study.\n* Unable or unwilling to give signed informed consent prior to participation in any study-related procedures.'}, 'identificationModule': {'nctId': 'NCT01244334', 'briefTitle': 'Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Cincinnati Eye Institute Northern Kentucky'}, 'officialTitle': 'A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal Edema.', 'orgStudyIdInfo': {'id': 'SEMC 5/2009-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Difluprednate Ophthalmic Emulsion 0.05%', 'interventionNames': ['Drug: Difluprednate ophthalmic emulsion 0.05%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone acetate suspension 0.1%', 'interventionNames': ['Drug: Prednisolone acetate 1%']}], 'interventions': [{'name': 'Difluprednate ophthalmic emulsion 0.05%', 'type': 'DRUG', 'otherNames': ['Durezol'], 'description': 'Difluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.', 'armGroupLabels': ['Difluprednate Ophthalmic Emulsion 0.05%']}, {'name': 'Prednisolone acetate 1%', 'type': 'DRUG', 'otherNames': ['Prednisolone acetate'], 'description': 'Prednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.', 'armGroupLabels': ['Prednisolone acetate suspension 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '11563', 'city': 'Lynbrook', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Long Island', 'geoPoint': {'lat': 40.65483, 'lon': -73.6718}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Eyecare', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}], 'overallOfficials': [{'name': 'Edward J Holland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cincinnati Eye Institute'}, {'name': 'Eric D Donnenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants of Long Island'}, {'name': 'Kerry S Solomon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Eyecare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edward J. Holland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sirion Therapeutics, Inc.', 'class': 'INDUSTRY'}, {'name': 'Alcon Research', 'class': 'INDUSTRY'}, {'name': 'Parsons Medical Communications', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor Investigator', 'investigatorFullName': 'Edward J. Holland', 'investigatorAffiliation': 'Cincinnati Eye Institute Northern Kentucky'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-07-29', 'type': 'RELEASE'}, {'date': '2013-10-08', 'type': 'RESET'}, {'date': '2014-08-11', 'type': 'RELEASE'}, {'date': '2014-08-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Edward J. Holland, Sponsor Investigator, Cincinnati Eye Institute Northern Kentucky'}}}}