Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-28 @ 7:04 AM
Study NCT ID:
NCT00695435
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2008-06-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tobramycin Tear Concentrations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014031', 'term': 'Tobramycin'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D009328', 'term': 'Nebramycin'}, {'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888.451.3937; 817.568.6725', 'title': 'Alcon Clinical', 'organization': 'Alcon Research, LTD'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension', 'description': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TOBREX®', 'description': 'TOBREX® Ophthalmic Solution', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TOBRADEX®', 'description': 'TOBRADEX® Ophthalmic Suspension', 'otherNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tobramycin Tear Concentration Cmax (Maximum Concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension', 'description': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension'}, {'id': 'OG001', 'title': 'TOBREX® Ophthalmic Solution', 'description': 'TOBREX® Ophthalmic Solution'}, {'id': 'OG002', 'title': 'TOBRADEX® Ophthalmic Suspension', 'description': 'TOBRADEX® Ophthalmic Suspension'}], 'classes': [{'categories': [{'measurements': [{'value': '853', 'spread': '618', 'groupId': 'OG000'}, {'value': '527', 'spread': '428', 'groupId': 'OG001'}, {'value': '542', 'spread': '425', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2, 4, 6, 12, and 18 minutes', 'description': "Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period.", 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tobramycin Tear Concentration Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension', 'description': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension'}, {'id': 'OG001', 'title': 'TOBREX® Ophthalmic Solution', 'description': 'TOBREX® Ophthalmic Solution'}, {'id': 'OG002', 'title': 'TOBRADEX® Ophthalmic Suspension', 'description': 'TOBRADEX® Ophthalmic Suspension'}], 'classes': [{'categories': [{'measurements': [{'value': '6124', 'spread': '4776', 'groupId': 'OG000'}, {'value': '2119', 'spread': '1820', 'groupId': 'OG001'}, {'value': '2484', 'spread': '2182', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 to 18 minutes post administration', 'description': 'Trapezoidal AUC was calculated from 2 to 18 minutes.', 'unitOfMeasure': 'min*ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX', 'description': 'Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX'}, {'id': 'FG001', 'title': 'Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX', 'description': 'Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX'}, {'id': 'FG002', 'title': 'TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05%', 'description': 'Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Randomized, single center (Alcon Eye Clinic),', 'preAssignmentDetails': 'Treatment randomization schedules were generated and maintained by the Alcon SAS Programming group. Only when the data were verified and validated and the database locked were the appropriate personnel unmasked.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Overall Study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2010-02-23', 'studyFirstSubmitDate': '2008-06-09', 'resultsFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2008-06-09', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-15', 'studyFirstPostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tobramycin Tear Concentration Cmax (Maximum Concentration)', 'timeFrame': '2, 4, 6, 12, and 18 minutes', 'description': "Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period."}], 'secondaryOutcomes': [{'measure': 'Tobramycin Tear Concentration Area Under the Curve (AUC)', 'timeFrame': '2 to 18 minutes post administration', 'description': 'Trapezoidal AUC was calculated from 2 to 18 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['normal volunteers', 'anti-infective', 'tobramycin'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n* Visual Acuity (VA) of 0.6 logMAR or better\n* Tear meniscus height of ≥ 0.3mm at Visit 1.\n* No concomitant topical ocular medications, including artificial tears, during the study period\n\nExclusion\n\n* ocular hypertension, iritis or uveitis, glaucoma\n* ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months\n* epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye\n* lacrimal duct obstruction, dry eye, ocular allergies.\n* contact lens within 7 days of Visit 1.\n* ocular medications within 14 days of Visit 1.'}, 'identificationModule': {'nctId': 'NCT00695435', 'briefTitle': 'Tobramycin Tear Concentrations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers', 'orgStudyIdInfo': {'id': 'C-08-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension', 'description': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension', 'interventionNames': ['Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TOBREX® Ophthalmic Solution', 'description': 'TOBREX® Ophthalmic Solution', 'interventionNames': ['Drug: TOBREX Ophthalmic Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TOBRADEX® Ophthalmic Suspension', 'description': 'TOBRADEX® Ophthalmic Suspension', 'interventionNames': ['Drug: TOBRADEX Ophthalmic Suspension']}], 'interventions': [{'name': 'TOBRADEX Ophthalmic Suspension', 'type': 'DRUG', 'description': 'TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline', 'armGroupLabels': ['TOBRADEX® Ophthalmic Suspension']}, {'name': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension', 'type': 'DRUG', 'description': 'Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline', 'armGroupLabels': ['Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension']}, {'name': 'TOBREX Ophthalmic Solution', 'type': 'DRUG', 'description': 'TOBREX Ophthalmic Solution 1 drop each eye at baseline', 'armGroupLabels': ['TOBREX® Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center For Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Michael Brubaker', 'oldOrganization': 'Alcon'}}}}