Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT00673959
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2008-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Comfort of Lubricant Eye Drop FID 111421
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, '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 onther than Contractors, the data arising out of the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lubricant Eye Drop FID 111421', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Optive Lubricant Eye Drop', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Drop Comfort Upon Instillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubricant Eye Drop FID 111421'}, {'id': 'OG001', 'title': 'Optive Lubricant Eye Drop'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'upon instillation', 'description': 'Drop comfort grading scale is a scale from 0 to 9, 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': 'Lubricant Drops, Then Optive Drops', 'description': 'Patients received Lubricant Drops first, then received Optive Drops'}, {'id': 'FG001', 'title': 'Optive Drops, Then Lubricant Drops', 'description': 'Patients received Optive Drops first, then received Lubricant Drops'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '20 Dry Eye Subjects', 'preAssignmentDetails': 'Randomized, double-masked, crossover'}, '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': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2008-05-02', 'resultsFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2008-05-06', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-23', 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drop Comfort Upon Instillation', 'timeFrame': 'upon instillation', 'description': 'Drop comfort grading scale is a scale from 0 to 9, 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 the acute comfort and blurring profile between two artificial tears products 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* Must not have worn contact lenses for 1 week preceding enrollment\n\nExclusion Criteria:\n\n* Age related'}, 'identificationModule': {'nctId': 'NCT00673959', 'briefTitle': 'Acute Comfort of Lubricant Eye Drop FID 111421', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-07-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lubricant Eye Drop FID 111421', 'description': 'Lubricant Eye Drop FID 111421 1 drop each eye one time', 'interventionNames': ['Other: Lubricant Eye Drop FID 111421']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optive Lubricant Eye Drop', 'description': 'Optive Lubricant Eye Drop 1 drop each eye one time', 'interventionNames': ['Other: Optive Lubricant Eye Drop']}], 'interventions': [{'name': 'Lubricant Eye Drop FID 111421', 'type': 'OTHER', 'description': 'Lubricant Eye Drop FID 111421 1 drop each eye one time', 'armGroupLabels': ['Lubricant Eye Drop FID 111421']}, {'name': 'Optive Lubricant Eye Drop', 'type': 'OTHER', 'description': 'Optive Lubricant Eye Drop 1 drop each eye one time', 'armGroupLabels': ['Optive Lubricant Eye Drop']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}