Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 3:34 AM
Study NCT ID:
NCT01518868
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2012-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Feasibility of a High Add Multi Focal 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 (262 eyes) were assessed for AEs. Participants/eyes received both treatment groups in this cross-over study.', 'eventGroups': [{'id': 'EG000', 'title': 'Investigational Contact Lens', 'description': 'multifocal high add soft contact lens\n\nInvestigational contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week.\n\nInvestigational contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week.\n\nInvestigational contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one week', 'otherNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PureVision Contact Lens', 'description': 'Multi-focal contact lens\n\nPureVision contact lens: Worn on a daily wear basis by adapted monovision soft contact lens wearers for one week\n\nPureVision contact lens: Worn on a daily wear basis by adapted multifocal soft contact wearers for one week.\n\nPureVision contact lens: Worn on a daily wear basis by adapted spherical soft contact lens wearers who may also use spectacles for near vision correction for one week', 'otherNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}, {'units': 'eye', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Contact Lens', 'description': 'multifocal high add soft contact lens\n\nInvestigational contact lens: Worn on a daily wear basis for one week.'}, {'id': 'OG001', 'title': 'PureVision Contact Lens', 'description': 'Multi-focal contact lens\n\nPureVision contact lens: Worn on a daily wear basis for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.079', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '0.090', 'spread': '0.091', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 2 weeks 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': 'eye', 'denomUnitsSelected': 'eye', 'populationDescription': 'There were 238 eyes assessed for visual acuity for this outcome measure. Participants/eyes received both treatment groups.'}, {'type': 'SECONDARY', 'title': 'Symptoms/Complaints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational Contact Lens', 'description': 'multifocal high add soft contact lens\n\nInvestigational contact lens: Worn on a daily wear basis for one week.'}, {'id': 'OG001', 'title': 'PureVision Contact Lens', 'description': 'Multi-focal contact lens\n\nPureVision contact lens: Worn on a daily wear basis for one week'}], 'classes': [{'title': 'Burning/stinging upon insertion', 'categories': [{'measurements': [{'value': '95.6', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '92.5', 'spread': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'Comfort upon insertion', 'categories': [{'measurements': [{'value': '89.4', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Comfort at end of day', 'categories': [{'measurements': [{'value': '75.3', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '64.9', 'spread': '28.8', 'groupId': 'OG001'}]}]}, {'title': 'Overall comfort', 'categories': [{'measurements': [{'value': '81.6', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '26.7', 'groupId': 'OG001'}]}]}, {'title': 'Dryness', 'categories': [{'measurements': [{'value': '80.3', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '26.4', 'groupId': 'OG001'}]}]}, {'title': 'Itchiness', 'categories': [{'measurements': [{'value': '91.9', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '86.8', 'spread': '22.1', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '91.4', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '86.9', 'spread': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Distance vision', 'categories': [{'measurements': [{'value': '67.7', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '59.3', 'spread': '30.8', 'groupId': 'OG001'}]}]}, {'title': 'Vision at intermediate distance', 'categories': [{'measurements': [{'value': '80.5', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '25.8', 'groupId': 'OG001'}]}]}, {'title': 'Vision at near distance', 'categories': [{'measurements': [{'value': '65.0', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '58.8', 'spread': '30.8', 'groupId': 'OG001'}]}]}, {'title': 'Overall vision', 'categories': [{'measurements': [{'value': '66.7', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '56.2', 'spread': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'Ease of handling/insertion', 'categories': [{'measurements': [{'value': '86.5', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '84.3', 'spread': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Ease of handling/removal', 'categories': [{'measurements': [{'value': '88.6', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '86.2', 'spread': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Overall impression', 'categories': [{'measurements': [{'value': '73.3', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '61.1', 'spread': '29.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 2 weeks 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 238 eyes assessed for symptoms/complaints for this outcome measure. Participants/eyes received both treatment groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Investigational Contact Lens Then PureVision Contact Lens', 'description': 'multifocal high add soft contact lens\n\nInvestigational contact lens: Worn on a daily wear basis for one week.\n\nMulti-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week'}, {'id': 'FG001', 'title': 'PureVision Contact Lens', 'description': 'Multi-focal contact lens then Investigational Contact Lens\n\nPureVision contact lens: Worn on a daily wear basis for one week\n\nmultifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], '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': 'Participants received both treatment groups in this cross-over study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '4.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demography was collected for 124 eligible, dispensed participants. Participants received both treatment groups in this cross-over study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2012-01-24', 'resultsFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-09', 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'At 2 weeks 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 2 weeks 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 the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.'}, '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* Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.\n* Have no active ocular disease or allergic conjunctivitis.\n* Must not be using any topical ocular medications.\n* Must habitually use a lens care product for lens cleaning, disinfecting, and storage.\n\nExclusion Criteria:\n\n* Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator\'s judgment, interferes with contact lens wear.\n* Any "Present" finding during the slit lamp examination that, in the Investigator\'s judgment, interferes with contact lens wear.\n* Anisometropia (spherical equivalent) of greater than 2.00 D.\n* Any systemic disease affecting ocular health.\n* Using any systemic or topical medications that will affect ocular physiology or lens performance.\n* Allergic to any component in the study products.\n* Ocular astigmatism of greater than 1.00 D in either eye.\n* Have had any corneal surgery (ie, refractive surgery).\n* Uses AMO Ultra Care as their habitual lens care regimen.\n* Is a toric contact lens wearer.\n* Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.\n* An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.'}, 'identificationModule': {'nctId': 'NCT01518868', 'briefTitle': 'A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens', 'orgStudyIdInfo': {'id': '743E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational contact lens', 'description': 'multifocal high add soft contact lens', 'interventionNames': ['Device: Investigational contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PureVision contact lens', 'description': 'Multi-focal contact lens', 'interventionNames': ['Device: PureVision contact lens']}], 'interventions': [{'name': 'Investigational contact lens', 'type': 'DEVICE', 'description': 'Worn on a daily wear basis for one week.', 'armGroupLabels': ['Investigational contact lens']}, {'name': 'PureVision contact lens', 'type': 'DEVICE', 'description': 'Worn on a daily wear basis for one week', 'armGroupLabels': ['PureVision 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': 'Beverly J Barna, CCRA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}