Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00934102
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2009-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cclr2@uwaterloo.ca', 'phone': '1-519-888-4742', 'title': 'Craig Woods, PhD, FAAO / Research Manager', 'organization': 'University of Waterloo'}, 'certainAgreement': {'otherDetails': 'No distribution of trial-specific information without express written permission of director.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the duration of the trial: 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Lotrafilcon A', 'description': 'Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Narafilcon A', 'description': 'Experimental, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Galyfilcon A', 'description': 'Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Front Surface Lens Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A', 'description': 'Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.'}, {'id': 'OG001', 'title': 'Narafilcon A', 'description': 'Investigational, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.'}, {'id': 'OG002', 'title': 'Galyfilcon A', 'description': 'Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 2, Day 6', 'description': "Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per Protocol. Only the data from participants who completed all study visits were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Narafilcon A / Lotrafilcon A', 'description': 'Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.'}, {'id': 'FG001', 'title': 'Narafilcon A / Galyfilcon A', 'description': 'Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.'}, {'id': 'FG002', 'title': 'Lotrafilcon A / Galyfilcon A', 'description': 'Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.'}], 'periods': [{'title': 'Period 1, One Night of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2, 7 Days/6 Nights of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of the 57 subjects screened for the study, 11 did not start Period 1 due to personal reasons (7) and non-suitability (4). Period 1 established Day One measurements in order to monitor changes during Period 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.23', 'spread': '4.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2009-07-06', 'resultsFirstSubmitDate': '2010-11-01', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-01', 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Front Surface Lens Deposits', 'timeFrame': 'Period 2, Day 6', 'description': "Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is at least 17 years of age and has full legal capacity to volunteer\n* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction\n* Has had an ocular examination in the last two years\n* Is a current soft (hydrogel or silicone hydrogel) contact lens wearer\n* Has clear corneas and no active ocular disease\n* Can be successfully fit with the lenses to be used in the study\n* Other protocol-defined inclusion/exclusion criteria may apply\n\nExclusion Criteria:\n\n* Is pregnant or lactating\n* Has undergone corneal refractive surgery\n* Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00934102', 'acronym': 'QUINCE', 'briefTitle': 'Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)', 'orgStudyIdInfo': {'id': 'P-368-C-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lotrafilcon A', 'description': 'Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.', 'interventionNames': ['Device: Lotrafilcon A contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Narafilcon A', 'description': 'Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.', 'interventionNames': ['Device: Narafilcon A contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Galyfilcon A', 'description': 'Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.', 'interventionNames': ['Device: Galyfilcon A contact lens']}], 'interventions': [{'name': 'Narafilcon A contact lens', 'type': 'DEVICE', 'description': 'Investigational, silicone hydrogel, spherical soft contact lens', 'armGroupLabels': ['Narafilcon A']}, {'name': 'Lotrafilcon A contact lens', 'type': 'DEVICE', 'description': 'Commercially marketed, silicone hydrogel, spherical soft contact lens', 'armGroupLabels': ['Lotrafilcon A']}, {'name': 'Galyfilcon A contact lens', 'type': 'DEVICE', 'description': 'Commercially marketed, silicone hydrogel, spherical soft contact lens', 'armGroupLabels': ['Galyfilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Contact Lens Research: University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Waterloo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}