Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT00909792
Status:
COMPLETED
Last Update Posted:
2012-06-29
First Post:
2009-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], '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 pre-clinical and/or clinical data or impressions from this trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '46 days, duration of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Lotrafilcon B', 'description': 'Silicone hydrogel, soft, multifocal contact lens', 'otherNumAtRisk': 256, 'otherNumAffected': 0, 'seriousNumAtRisk': 256, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Senofilcon A', 'description': 'Silicone hydrogel, soft, multifocal contact lens', 'otherNumAtRisk': 258, 'otherNumAffected': 0, 'seriousNumAtRisk': 258, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B Multifocal Contact Lens', 'description': 'Silicone hydrogel, soft, multifocal contact lens'}, {'id': 'OG001', 'title': 'Senofilcon A Multifocal Contact Lens', 'description': 'Silicone hydrogel, soft, multifocal contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 week of wear', 'description': 'Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol. Analysis excluded major protocol deviations as determined by masked review.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lotrafilcon B / Senofilcon A', 'description': 'Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.'}, {'id': 'FG001', 'title': 'Senofilcon A / Lotrafilcon B', 'description': 'Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant discontinued between Period 1 and Period 2 due to lack of efficacy.', 'groupId': 'FG000', 'numSubjects': '129'}, {'comment': 'Two discontinuations between P1 \\& P2: 1 for fail inc/exc criteria; 1 for lack of efficacy.', 'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Biomicroscopy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'This reporting group includes all enrolled and dispensed subjects.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '4.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '222', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2009-05-27', 'resultsFirstSubmitDate': '2010-09-16', 'studyFirstSubmitQcDate': '2009-05-27', 'lastUpdatePostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-10-06', 'studyFirstPostDateStruct': {'date': '2009-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity', 'timeFrame': 'After 1 week of wear', 'description': 'Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.'}]}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 35 years of age\n* Best-corrected distance visual acuity of at least 20/40 in each eye.\n* Spectacle add between +0.75D and +1.50D (inclusive).\n* Able to be fit in available study sphere powers (-1.00 to -5.00D)\n* Currently wearing soft contact lenses at least 5 days a week.\n* Other protocol inclusion/exclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury or surgery within twelve weeks immediately prior to enrollment.\n* Currently enrolled in an ophthalmic clinical trial.\n* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.\n* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.\n* Astigmatism ≥ 1.00D.\n* Currently wearing either of the study products.\n* Other protocol inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00909792', 'briefTitle': 'Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products', 'orgStudyIdInfo': {'id': 'P-319-C-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lotrafilcon B / Senofilcon A', 'description': 'Lotrafilcon B, followed by Senofilcon A', 'interventionNames': ['Device: Lotrafilcon B', 'Device: Senofilcon A']}, {'type': 'OTHER', 'label': 'Senofilcon A / Lotrafilcon B', 'description': 'Senofilcon A, followed by Lotrafilcon B', 'interventionNames': ['Device: Lotrafilcon B', 'Device: Senofilcon A']}], 'interventions': [{'name': 'Lotrafilcon B', 'type': 'DEVICE', 'description': 'Silicone hydrogel, soft, multifocal contact lens', 'armGroupLabels': ['Lotrafilcon B / Senofilcon A', 'Senofilcon A / Lotrafilcon B']}, {'name': 'Senofilcon A', 'type': 'DEVICE', 'description': 'Silicone hydrogel, soft, multifocal contact lens', 'armGroupLabels': ['Lotrafilcon B / Senofilcon A', 'Senofilcon A / Lotrafilcon B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}