Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 1:11 AM
Study NCT ID:
NCT00756093
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2008-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops
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': 'D011092', 'term': 'Polyethylene Glycols'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888.451.3937; 817.568.6725', 'title': 'Alcon Clinical', 'organization': 'Alcon Research Ltd'}, 'certainAgreement': {'otherDetails': 'The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study. Alcon reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Systane Ultra Lubricant Eye Drops', 'description': 'Systane Ultra Lubricant Eye Drops', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Optive Lubricant Eye Drops', 'description': 'Optive Lubricant Eye Drops', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Blink Tears', 'description': 'Blink Tears', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'GenTeal Moderate Lubricant Eye Drops', 'description': 'GenTeal Moderate Lubricant Eye Drops', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Drop Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Ultra Lubricant Eye Drops', 'description': 'Systane Ultra Lubricant Eye Drops'}, {'id': 'OG001', 'title': 'Optive Lubricant Eye Drops', 'description': 'Optive Lubricant Eye Drops'}, {'id': 'OG002', 'title': 'Blink Tears', 'description': 'Blink Tears'}, {'id': 'OG003', 'title': 'GenTeal Moderate Lubricant Eye Drops', 'description': 'GenTeal Moderate Lubricant Eye Drops'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '1.84', 'spread': '2.19', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '1.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'once upon instillation', 'description': 'Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Systane, Then Optive, Then Blink Tears, Then GenTeal Moderate', 'description': 'Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last.'}, {'id': 'FG001', 'title': 'Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane', 'description': 'Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane'}, {'id': 'FG002', 'title': 'Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive', 'description': 'Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last'}, {'id': 'FG003', 'title': 'GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears', 'description': 'Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Fourth Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '20 dry eye subjects', 'preAssignmentDetails': 'randomized, double-masked, cross-over design'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', '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': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2008-09-17', 'resultsFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2008-09-17', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-23', 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drop Comfort', 'timeFrame': 'once upon instillation', 'description': 'Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye, Artificial Tears,'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented diagnosis of dry eye\n\nExclusion Criteria:\n\n* use of topical ocular drops within 2 hours preceding enrollment'}, 'identificationModule': {'nctId': 'NCT00756093', 'briefTitle': 'Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'M-08-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systane Ultra Lubricant Eye Drops', 'description': 'Systane Ultra Lubricant Eye Drops 1 drop each one time', 'interventionNames': ['Other: Systane Ultra Lubricant Eye Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optive Lubricant Eye Drops', 'description': 'Optive Lubricant Eye Drops 1 drop each eye one time', 'interventionNames': ['Other: Optive Lubricant Eye Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blink Tears', 'description': 'Blink Tears 1 drop each eye one time', 'interventionNames': ['Other: Blink Tears']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GenTeal Moderate Lubricant Eye Drops', 'description': 'GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time', 'interventionNames': ['Other: GenTeal Moderate Lubricant Eye Drops']}], 'interventions': [{'name': 'Systane Ultra Lubricant Eye Drops', 'type': 'OTHER', 'description': 'Systane Ultra Lubricant Eye Drops one drop each eye one time', 'armGroupLabels': ['Systane Ultra Lubricant Eye Drops']}, {'name': 'Optive Lubricant Eye Drops', 'type': 'OTHER', 'description': 'Optive Lubricant Eye Drops one drop each eye one time', 'armGroupLabels': ['Optive Lubricant Eye Drops']}, {'name': 'Blink Tears', 'type': 'OTHER', 'description': 'Blink Tears one drop each eye one time', 'armGroupLabels': ['Blink Tears']}, {'name': 'GenTeal Moderate Lubricant Eye Drops', 'type': 'OTHER', 'description': 'GenTeal Moderate Lubricant Eye Drops one drop each eye one time', 'armGroupLabels': ['GenTeal Moderate Lubricant Eye Drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Call Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}