Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 8:38 AM
Study NCT ID:
NCT00902850
Status:
COMPLETED
Last Update Posted:
2015-03-02
First Post:
2009-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens
Sponsor:
Organization:
Raw JSON
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Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SofLens Daily Disposable', 'description': 'SofLens Daily Disposable Lenses\n\nSofLens Daily Disposable: Lenses to be worn for 8-16 hours'}, {'id': 'FG001', 'title': 'Marketed 1 Day Contact Lens', 'description': 'Marketed 1 Day Contact Lens\n\nMarketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SofLens Daily Disposable', 'description': 'SofLens Daily Disposable Lenses\n\nSofLens Daily Disposable: Lenses to be worn for 8-16 hours'}, {'id': 'BG001', 'title': 'Marketed 1 Day Contact Lens', 'description': 'Marketed 1 Day Contact Lens\n\nMarketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '59'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '59'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-13', 'studyFirstSubmitDate': '2009-05-14', 'resultsFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2009-05-14', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-13', 'studyFirstPostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Performance', 'timeFrame': 'Insertion, 4 hours & End of Day', 'description': 'Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.\n* Have no active ocular disease or allergic conjunctivitis.\n* Not be using any topical ocular medications.\n\nExclusion Criteria:\n\n* Participating in a conflicting study.\n* Considered by the Investigator to not be a suitable candidate for participation.'}, 'identificationModule': {'nctId': 'NCT00902850', 'briefTitle': 'One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to 1-Day Acuvue TruEye Lenses', 'orgStudyIdInfo': {'id': 'ROC2-08-169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SofLens Daily Disposable', 'description': 'SofLens Daily Disposable Lenses', 'interventionNames': ['Device: SofLens Daily Disposable']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Marketed 1 Day Contact Lens', 'description': 'Marketed 1 Day Contact Lens', 'interventionNames': ['Device: Marketed 1 Day Contact Lens']}], 'interventions': [{'name': 'SofLens Daily Disposable', 'type': 'DEVICE', 'description': 'Lenses to be worn for 8-16 hours', 'armGroupLabels': ['SofLens Daily Disposable']}, {'name': 'Marketed 1 Day Contact Lens', 'type': 'DEVICE', 'description': 'Lenses to be worn for 8-16 hours', 'armGroupLabels': ['Marketed 1 Day Contact Lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb Research Clinic', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Robert Steffen, OD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}