Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT00808834
Status:
COMPLETED
Last Update Posted:
2012-06-29
First Post:
2008-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'priya.janakiraman@cibavision.com', 'phone': '1-800-241-7629', 'title': 'Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs', 'organization': 'CIBA VISION'}, 'certainAgreement': {'otherDetails': "For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days, duration of the trial.', 'description': 'Subjects wore 2 pairs of contact lenses, 15 minutes per pair.', 'eventGroups': [{'id': 'EG000', 'title': 'Senofilcon A', 'description': 'Commercially marketed, silicone hydrogel, spherical, soft contact lens', 'otherNumAtRisk': 196, 'otherNumAffected': 0, 'seriousNumAtRisk': 196, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lotrafilcon A', 'description': 'Investigational, silicone hydrogel, spherical, soft contact lens', 'otherNumAtRisk': 196, 'otherNumAffected': 0, 'seriousNumAtRisk': 196, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort After Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Commercially marketed, silicone hydrogel, spherical, soft contact lens'}, {'id': 'OG001', 'title': 'Lotrafilcon A', 'description': 'Investigational, silicone hydrogel, spherical, soft contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30-60 seconds after initial insertion', 'description': 'Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Scale 1-10', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Senofilcon A / Lotrafilcon A', 'description': 'Senofilcon A, followed by Lotrafilcon A'}, {'id': 'FG001', 'title': 'Lotrafilcon A / Senofilcon A', 'description': 'Lotrafilcon A, followed by Senofilcon A'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'This reporting group includes all enrolled and exposed subjects.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '12.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '141', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', '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': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2008-12-11', 'resultsFirstSubmitDate': '2010-06-18', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-16', 'studyFirstPostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort After Insertion', 'timeFrame': '30-60 seconds after initial insertion', 'description': 'Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently wearing soft contact lenses\n* Replaces lenses on a weekly or longer schedule\n* Other protocol-defined inclusion/exclusion criteria may apply\n\nExclusion Criteria:\n\n* Requires concurrent ocular medication\n* Eye injury or surgery within twelve weeks immediately prior to enrollment\n* Currently wearing soft toric lens wearers\n* Those who dispose of their soft lenses on a daily basis\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00808834', 'briefTitle': 'Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses', 'orgStudyIdInfo': {'id': 'P-335-C-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Senofilcon A / Lotrafilcon A', 'description': 'Senofilcon A, followed by Lotrafilcon A', 'interventionNames': ['Device: Lotrafilcon A contact lens', 'Device: Senofilcon A contact lens']}, {'type': 'OTHER', 'label': 'Lotrafilcon A / Senofilcon A', 'description': 'Lotrafilcon A, followed by Senofilcon A', 'interventionNames': ['Device: Lotrafilcon A contact lens', 'Device: Senofilcon A contact lens']}], 'interventions': [{'name': 'Lotrafilcon A contact lens', 'type': 'DEVICE', 'description': 'Investigational, silicone hydrogel, spherical, soft contact lens', 'armGroupLabels': ['Lotrafilcon A / Senofilcon A', 'Senofilcon A / Lotrafilcon A']}, {'name': 'Senofilcon A contact lens', 'type': 'DEVICE', 'description': 'Commercially marketed, silicone hydrogel, spherical, soft contact lens', 'armGroupLabels': ['Lotrafilcon A / Senofilcon A', 'Senofilcon A / Lotrafilcon A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}