Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT00532961
Status:
COMPLETED
Last Update Posted:
2011-12-08
First Post:
2007-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex
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': 'D000069559', 'term': 'Loteprednol Etabonate'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000078162', 'term': 'Tobramycin, Dexamethasone Drug Combination'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D014031', 'term': 'Tobramycin'}, {'id': 'D009328', 'term': 'Nebramycin'}, {'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-07', 'studyFirstSubmitDate': '2007-09-20', 'studyFirstSubmitQcDate': '2007-09-20', 'lastUpdatePostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular comfort/tolerability', 'timeFrame': 'Day 1, 3, 8, 15, 22 and 29'}, {'measure': 'Intraocular pressure measurements', 'timeFrame': 'Day 1, 3, 8,15, 22 and 29'}], 'secondaryOutcomes': [{'measure': 'Assessment of safety', 'timeFrame': 'Througout 28-day study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '18577309', 'type': 'DERIVED', 'citation': 'Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL. Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Curr Med Res Opin. 2008 Aug;24(8):2219-27. doi: 10.1185/03007990802231981. Epub 2008 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* in good general health based on investigator judgment\n* able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study\n* possessing a best corrected visual acuity of at least 20/40 in each eye\n* for females, using reliable contraception and a negative urine pregnancy test prior to study entry\n\nExclusion Criteria:\n\n* contact lenses worn within 30 days prior to enrollment or during study period\n* known hypersensitivity to study medication or any component\n* presence of significant ocular or systemic disease that might interfere with the interpretation of the results\n* a need for administration of chronic topical ocular or systemic medications of any kind during the study.\n* participation in an opthalmic drug or device research study within 30 days prior to entry'}, 'identificationModule': {'nctId': 'NCT00532961', 'briefTitle': 'Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers', 'orgStudyIdInfo': {'id': '372'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zylet', 'description': 'Zylet (loteprednol etabonate and tobramycin)', 'interventionNames': ['Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobradex', 'description': 'TobraDex (dexamethasone and tobramycin)', 'interventionNames': ['Drug: Dexamethasone 0.1% and tobramycin 0.3%']}], 'interventions': [{'name': 'Loteprednol etabonate 0.5% and tobramycin 0.3%', 'type': 'DRUG', 'otherNames': ['Zylet'], 'description': 'ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days', 'armGroupLabels': ['Zylet']}, {'name': 'Dexamethasone 0.1% and tobramycin 0.3%', 'type': 'DRUG', 'otherNames': ['TobraDex'], 'description': 'ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.', 'armGroupLabels': ['Tobradex']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Timothy L Comstock, DO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}