Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 11:22 AM
Study NCT ID:
NCT02939950
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2015-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
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': 'Daniel.Donatello@bausch.com', 'phone': '(585) 338-5306', 'title': 'Director of Clinical Operations', 'organization': 'Bausch Health Americas, Inc.'}, 'certainAgreement': {'otherDetails': 'Please contact Sponsor directly for additional information.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Month 12', 'description': 'Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.', 'eventGroups': [{'id': 'EG000', 'title': 'Bausch + Lomb Samfilcon A Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.', 'otherNumAtRisk': 405, 'deathsNumAtRisk': 405, 'otherNumAffected': 22, 'seriousNumAtRisk': 405, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bausch + Lomb Pure Vision Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.', 'otherNumAtRisk': 410, 'deathsNumAtRisk': 410, 'otherNumAffected': 14, 'seriousNumAtRisk': 410, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Peripheral Non-Progressive Non-Infectious Corneal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Symptomatic Corneal Infiltrative Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Corneal Staining greater than or equal to Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Ocular Event that necessitates temporary lens discontinuation for atleast two weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'High Contrast Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '652', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bausch + Lomb Samfilcon A Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.'}, {'id': 'OG001', 'title': 'Bausch + Lomb Pure Vision Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.065', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-0.047', 'spread': '0.071', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': "For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).", 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Analysis set included all eligible dispensed participants under the treatment they actually received. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bausch + Lomb Samfilcon A Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.'}, {'id': 'OG001', 'title': 'Bausch + Lomb Pure Vision Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 12', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all dispensed participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bausch + Lomb Samfilcon A Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.'}, {'id': 'FG001', 'title': 'Bausch + Lomb Pure Vision Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '812', 'numSubjects': '406'}, {'groupId': 'FG001', 'numUnits': '820', 'numSubjects': '410'}]}, {'type': 'Dispensed the Assigned Lenses', 'achievements': [{'groupId': 'FG000', 'numUnits': '810', 'numSubjects': '405'}, {'groupId': 'FG001', 'numUnits': '820', 'numSubjects': '410'}]}, {'type': 'Eligible at Baseline', 'achievements': [{'groupId': 'FG000', 'numUnits': '806', 'numSubjects': '403'}, {'groupId': 'FG001', 'numUnits': '804', 'numSubjects': '402'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '680', 'numSubjects': '340'}, {'groupId': 'FG001', 'numUnits': '658', 'numSubjects': '329'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '132', 'numSubjects': '66'}, {'groupId': 'FG001', 'numUnits': '162', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Positive slit lamp findings', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Chalazion upper lid', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of motivation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Unacceptable distance lens visual acuity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Military orders', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant Relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study related symptoms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Unacceptable lens movement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomized, not dispensed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Ineligible at Baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'preAssignmentDetails': 'A total of 1632 eyes from 816 study participants were enrolled, of which 1612 eyes from 806 study participants were randomized into 1:1 to wear either the Bausch + Lomb samfilcon A soft contact lens or Bausch + Lomb pure vision soft contact lens.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '805', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '806', 'groupId': 'BG000'}, {'value': '804', 'groupId': 'BG001'}, {'value': '1610', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bausch + Lomb Samfilcon A Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.'}, {'id': 'BG001', 'title': 'Bausch + Lomb Pure Vision Soft Contact Lens', 'description': 'Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '29.2', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '29.5', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'Analysis set included all eligible dispensed participants under the treatment they actually received.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 816}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2017-12-19', 'completionDateStruct': {'date': '2016-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2015-06-01', 'dispFirstSubmitQcDate': '2017-12-19', 'resultsFirstSubmitDate': '2019-11-22', 'studyFirstSubmitQcDate': '2016-10-18', 'dispFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-22', 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High Contrast Visual Acuity', 'timeFrame': 'Month 12', 'description': "For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters)."}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Baseline up to Month 12', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.', 'detailedDescription': 'Approximately 816 participants (1,632 eyes) will be enrolled in this 12-month randomized, parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the US.\n\nAt the Screening/Dispensing Visit, approximately one-half of the participants will be randomized to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test) and approximately one-half of the subjects will be randomized to receive Bausch + Lomb PureVision soft contact lenses (Control). Both groups will wear the assigned lenses bilaterally on a 7-day extended wear basis throughout the 12 month study. The lenses are to be worn overnight for up to six consecutive nights per week. The lenses are to be removed, cleaned and disinfected on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses at the beginning of each month. Lenses will be provided at the Screening/Dispensing, 3-Month, 6-Month and 9-Month Follow-Up visits to maintain a monthly replacement schedule. Participants will also be required to complete a paper diary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.\n* Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.\n* Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.\n* Participants must have clear central corneas and be free of any anterior segment disorders.\n* Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.\n\nExclusion Criteria:\n\n* Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.\n* Participants with an active ocular disease or who are using any ocular medication.\n* Participants with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.\n* Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.\n* Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.\n* Participants who currently wear monovision, multifocal, or toric contact lenses."}, 'identificationModule': {'nctId': 'NCT02939950', 'briefTitle': 'Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Soft Contact Lens When Worn on a 7-Day Extended Wear Basis', 'orgStudyIdInfo': {'id': '818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bausch + Lomb Samfilcon A Soft Contact Lens', 'description': 'Participants will wear Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month.', 'interventionNames': ['Device: Bausch + Lomb Samfilcon A Soft Contact Lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bausch + Lomb Pure Vision Soft Contact Lens', 'description': 'Participants will wear Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month.', 'interventionNames': ['Device: Bausch + Lomb Pure Vision Soft Contact Lens']}], 'interventions': [{'name': 'Bausch + Lomb Samfilcon A Soft Contact Lens', 'type': 'DEVICE', 'description': 'soft contact lenses', 'armGroupLabels': ['Bausch + Lomb Samfilcon A Soft Contact Lens']}, {'name': 'Bausch + Lomb Pure Vision Soft Contact Lens', 'type': 'DEVICE', 'description': 'soft contact lenses', 'armGroupLabels': ['Bausch + Lomb Pure Vision Soft Contact Lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13039', 'city': 'Cicero', 'state': 'New York', 'country': 'United States', 'facility': 'Cicero Family Eye Care', 'geoPoint': {'lat': 43.17562, 'lon': -76.11937}}], 'overallOfficials': [{'name': 'Johnson Varughese', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch Health Americas, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}