Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01120418
Status:
COMPLETED
Last Update Posted:
2012-08-13
First Post:
2010-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-10', 'studyFirstSubmitDate': '2010-05-07', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial cell density change between treatment group.', 'timeFrame': 'Baseline, 5 days', 'description': 'Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes.'}], 'secondaryOutcomes': [{'measure': 'Endothelial cell density change within treatment group', 'timeFrame': 'Baseline, 5 days', 'description': 'Change from baseline in endothelial cell density within eyes treated with besifloxacin ophthalmic suspension and within untreated fellow eyes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endothelial cell density', 'screening'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effect on corneal endothelial cell density changes when ISV-403 is administered for five (5) days compared to no drug treatment, in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have pin-holed Snellen visual acuity equal to or better than 20/40, in both eyes\n* Must be in good health (no current or past relevant medical/ocular history) based on the judgment of the Investigator\n* Must be willing to discontinue contact lens wear for the duration of the study\n\nExclusion Criteria:\n\n* Known hypersensitivity to fourth generation fluoroquinolone (SS734) or to any of the ingredients in the study medication Investigator determines could interfere with the study\n* History of extended or continuous wear contact lens use other than silicone hydrogels\n* History of intraocular surgery\n* Any topical ophthalmic medication, including tear substitutes, that cannot be discontinued during the study\n* Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study'}, 'identificationModule': {'nctId': 'NCT01120418', 'briefTitle': 'Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Randomized, Contralateral Study To Evaluate Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered 0.6% ISV-403 Three Times Daily For Five Days', 'orgStudyIdInfo': {'id': '507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Besifloxacin Ophthalmic Suspension 0.6%', 'description': 'Topical ocular administration three times daily (TID) for 5 days', 'interventionNames': ['Drug: Besifloxacin Ophthalmic Suspension 0.6%']}], 'interventions': [{'name': 'Besifloxacin Ophthalmic Suspension 0.6%', 'type': 'DRUG', 'otherNames': ['ISV-403'], 'description': 'administered 3 times a day for 5 days to one eye.', 'armGroupLabels': ['Besifloxacin Ophthalmic Suspension 0.6%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Laura Trusso, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}