Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-03 @ 2:22 AM
Study NCT ID:
NCT01455233
Status:
COMPLETED
Last Update Posted:
2011-10-19
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-08-06', 'releaseDate': '2012-06-28'}, {'resetDate': '2012-09-05', 'releaseDate': '2012-08-06'}, {'resetDate': '2017-09-22', 'releaseDate': '2017-09-22'}], 'estimatedResultsFirstSubmitDate': '2012-06-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522124', 'term': 'besifloxacin'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-18', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'corneal health', 'timeFrame': 'through day 28 post op', 'description': 'Endothelial Cell Count (day 7, day 28) Pachymetry (day 7, day 28) Corneal Fluorescein Staining (day 7, day 28) Biomicroscopy (day 1, day 7, day 28)'}], 'secondaryOutcomes': [{'measure': 'subject tolerance', 'timeFrame': 'day - 3 through day 28', 'description': 'reported adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cornea', 'ocular antibiotic', 'cataract surgery'], 'conditions': ['Corneal Health', 'Cataract Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.', 'detailedDescription': 'Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively.\n\nSixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or woen of any race, 18 years or older who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens\n* Study eye of patients who, in the opinion of the investigator, will experience improvement in visual acuity following surgery\n* Patients who are able to understand and sign an informed consent form that has been approved by an IRB\n\nExclusion Criteria:\n\n* Planned multiple procedures during cataract/IOL implantation surgery. Note: A planned limbal relaxing incision may be performed for the correction of astigmatism\n* Use of topical ocular or systemic antibiotics within 14 days prior to surgery and through study exit\n* History of or Fuch's Corneal Endothelial Dystrophy\n* Any ocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain in the study eye that is present during the baseline visit.\n* Recent (within 6 months) ocular trama to the operative eye (this includes intraocular surgery)\n* A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye\n* Currently diagnosed uncontrolled glaucoma in the operative eye\n* Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye\n* A visually nonfunctional fellow eye defined as a best corrected visual acuity \\</= 35 ETDRS letters (20/200 Snellen equivalent) or worse\n* Participation in any other investigational drug or device study within 30 days before cataract surgery\n* Known or suspected allergy or hypersensitivity to any component of either test article\n* Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:\n\n 1. they are breast feeding\n 2. they have a positive urine pregnancy test at screening\n 3. they are not willing to undergo a urine pregnancy test upon entering or exiting the study\n 4. they intend to become pregnant during the duration of the study; or,\n 5. they do not agree to use adequate birth control methods for the duration of the study"}, 'identificationModule': {'nctId': 'NCT01455233', 'acronym': 'STB-01', 'briefTitle': '2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ophthalmology Consultants, Ltd.'}, 'officialTitle': 'Phase IV Study: A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance Versus Vigamox Prophylactically Pre and Post Operatively in Subjects Undergoing Routine Cataract Surgery', 'orgStudyIdInfo': {'id': 'STB-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'besivance', 'description': 'ocular antibiotic', 'interventionNames': ['Drug: vigamox']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vigamox', 'description': 'ocular antibiotic', 'interventionNames': ['Drug: besivance']}], 'interventions': [{'name': 'besivance', 'type': 'DRUG', 'otherNames': ['besifloxacin ophthalmic suspension 0.6%'], 'description': 'topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery', 'armGroupLabels': ['vigamox']}, {'name': 'vigamox', 'type': 'DRUG', 'otherNames': ['moxifloxacin hydrochloride ophthalmic solution 0.5%'], 'description': 'topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery', 'armGroupLabels': ['besivance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Consultants, Ltd', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Ranjan Maholtra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology Associates'}, {'name': 'Joseph Gira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology Consultants'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ophthalmology Consultants, Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ophthalmology Associates, St Louis', 'class': 'OTHER'}, {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joseph Gira, M.D.', 'investigatorAffiliation': 'Ophthalmology Consultants, Ltd.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-06-28', 'type': 'RELEASE'}, {'date': '2012-08-06', 'type': 'RESET'}, {'date': '2012-08-06', 'type': 'RELEASE'}, {'date': '2012-09-05', 'type': 'RESET'}, {'date': '2017-09-22', 'type': 'RELEASE'}, {'date': '2017-09-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Joseph Gira, M.D., Principal Investigator, Ophthalmology Consultants, Ltd.'}}}}