Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT01539694
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2012-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.steffen@bausch.com', 'title': 'Study Director', 'organization': 'Bausch Health'}, 'certainAgreement': {'otherDetails': 'Contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': 'Adverse events (AEs) were not coded. Therefore, source vocabulary is not applicable. A total of 126 participants (252 eyes) were assessed for AEs. Participants/eyes received both treatment groups in this cross-over study.', 'eventGroups': [{'id': 'EG000', 'title': 'LD118033 Contact Lens', 'description': 'Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.\n\nLD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week', 'otherNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PureVision Multifocal Contact Lens', 'description': 'PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.\n\nPureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week.', 'otherNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LD118033 Contact Lens', 'description': 'Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.\n\nLD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week'}, {'id': 'OG001', 'title': 'PureVision Multifocal Contact Lens', 'description': 'PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.\n\nPureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.023', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.069', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 week follow up', 'description': 'Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups.'}, {'type': 'SECONDARY', 'title': 'Symptoms/Complaints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LD118033 Contact Lens', 'description': 'Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.\n\nLD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week'}, {'id': 'OG001', 'title': 'PureVision Multifocal Contact Lens', 'description': 'PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.\n\nPureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week.'}], 'classes': [{'title': 'Burning/stinging upon insertion', 'categories': [{'measurements': [{'value': '91.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '89.2', 'spread': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'Comfort upon insertion', 'categories': [{'measurements': [{'value': '87.0', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '83.9', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Comfort at end of day', 'categories': [{'measurements': [{'value': '72.5', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '68.1', 'spread': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Overall comfort', 'categories': [{'measurements': [{'value': '79.2', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '74.6', 'spread': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Dryness', 'categories': [{'measurements': [{'value': '78.7', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '75.2', 'spread': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'Itchiness', 'categories': [{'measurements': [{'value': '89.1', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '84.5', 'spread': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '91.9', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '87.0', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Distance Vision', 'categories': [{'measurements': [{'value': '69.3', 'spread': '30.4', 'groupId': 'OG000'}, {'value': '76.5', 'spread': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Vision at intermediate distance', 'categories': [{'measurements': [{'value': '81.2', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '80.7', 'spread': '18.3', 'groupId': 'OG001'}]}]}, {'title': 'Vision at near distance', 'categories': [{'measurements': [{'value': '76.3', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '72.2', 'spread': '26.2', 'groupId': 'OG001'}]}]}, {'title': 'Overall vision', 'categories': [{'measurements': [{'value': '72.9', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'Ease of handling/insertion', 'categories': [{'measurements': [{'value': '85.7', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '19.7', 'groupId': 'OG001'}]}]}, {'title': 'Ease of handling/removal', 'categories': [{'measurements': [{'value': '88.5', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '87.5', 'spread': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'Overall impression', 'categories': [{'measurements': [{'value': '24.7', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '74.6', 'spread': '22.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 week follow up', 'description': 'Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LD118033 Contact Lens Then PureVision Multifocal Contact Lens', 'description': 'Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.\n\nLD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week\n\nPureVision multifocal low add soft contact lens, to be worn on a daily wear basis.\n\nPureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week'}, {'id': 'FG001', 'title': 'PureVision Multifocal Contact Lens Then LD118033 Contact Lens', 'description': 'PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.\n\nPureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week.\n\nInvestigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.\n\nLD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 126 participants (252 eyes) were enrolled. One-half of the participants were randomized to receive the investigational contact lens during the first crossover period, and the other half were randomized to receive the PureVision contact lens during the first crossover period. The participants crossed over to the other group at 1 week.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'All participants/eyes received both treatment groups.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'spread': '4.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demography was collected for 124 eligible, dispensed participants. Participants received both treatment groups.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2012-02-15', 'resultsFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-09', 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'At 1 week follow up', 'description': 'Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).'}], 'secondaryOutcomes': [{'measure': 'Symptoms/Complaints', 'timeFrame': 'At 1 week follow up', 'description': 'Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have physiologically normal anterior segments.\n* Be adapted wearers of soft contact lenses and wear a lens in each eye.\n* Be presbyopic and require near add correction in each eye.\n* Have no active ocular disease or allergic conjunctivitis.\n* Must not be using any topical ocular medications.\n\nExclusion Criteria:\n\n* Any Grade 2 or greater finding during the slit lamp examination.\n* Any scar or neovascularization within the central 4mm of the cornea.\n* Any "Present" finding during the slit lamp examination that, in the Investigator\'s judgment, interferes with contact lens wear.\n* Allergic to any component in the study products.\n* Any systemic disease affecting ocular health.\n* Using any systemic or topical medications that will affect ocular physiology or lens performance.\n* An active ocular disease, any corneal infiltrative response or are using any ocular medications.'}, 'identificationModule': {'nctId': 'NCT01539694', 'briefTitle': 'A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens', 'orgStudyIdInfo': {'id': '744E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LD118033 contact lens', 'description': 'Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.', 'interventionNames': ['Device: LD118033 contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PureVision multifocal contact lens', 'description': 'PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.', 'interventionNames': ['Device: PureVision multifocal contact lens']}], 'interventions': [{'name': 'LD118033 contact lens', 'type': 'DEVICE', 'description': 'Multifocal contact lens worn on a daily wear basis for 1 week', 'armGroupLabels': ['LD118033 contact lens']}, {'name': 'PureVision multifocal contact lens', 'type': 'DEVICE', 'description': 'PureVision multifocal contact lens worn on a daily wear basis for 1 week.', 'armGroupLabels': ['PureVision multifocal contact lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb Incorporated', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Gerard Cairns, PhD, MCOptom', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}