Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-29 @ 8:46 PM
Study NCT ID:
NCT01211535
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2010-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-888-451-3937', 'title': 'Jami Kern, Ph.D.', 'organization': 'Alcon Global Medical Affairs'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study.', 'description': 'The safety population includes all participants who received study regimen.', 'eventGroups': [{'id': 'EG000', 'title': 'OPTI-FREE RepleniSH', 'description': 'OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ReNu Biotrue', 'description': 'ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OPTI-FREE RepleniSH', 'description': 'OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days'}, {'id': 'OG001', 'title': 'ReNu Biotrue', 'description': 'ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '87.40', 'groupId': 'OG000', 'lowerLimit': '83.82', 'upperLimit': '90.99'}, {'value': '88.79', 'groupId': 'OG001', 'lowerLimit': '85.21', 'upperLimit': '92.37'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '81.75', 'groupId': 'OG000', 'lowerLimit': '78.17', 'upperLimit': '85.33'}, {'value': '83.18', 'groupId': 'OG001', 'lowerLimit': '79.56', 'upperLimit': '86.79'}]}]}, {'title': 'Change from Baseline (Day 0) at Day 14', 'categories': [{'measurements': [{'value': '-5.65', 'groupId': 'OG000', 'lowerLimit': '-10.72', 'upperLimit': '-0.59'}, {'value': '-5.61', 'groupId': 'OG001', 'lowerLimit': '-10.70', 'upperLimit': '-0.52'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Day 14', 'description': 'Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OPTI-FREE RepleniSH', 'description': 'OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days'}, {'id': 'FG001', 'title': 'ReNu Biotrue', 'description': 'ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OPTI-FREE RepleniSH', 'description': 'OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days'}, {'id': 'BG001', 'title': 'ReNu Biotrue', 'description': 'ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '35.4', 'spread': '10.96', 'groupId': 'BG001'}, {'value': '34.3', 'spread': '10.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-15', 'studyFirstSubmitDate': '2010-09-28', 'resultsFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-15', 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14', 'timeFrame': 'Baseline (Day 0), Day 14', 'description': 'Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Soft contact lenses', 'Multi-purpose Solution'], 'conditions': ['Myopia', 'Astigmatism', 'Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently wearing silicone hydrogel contact lenses on a daily wear basis;\n* Currently using OPTI-FREE RepleniSH contact lens solution;\n* Generally healthy;\n* Normal ocular health;\n* Willing to follow study procedures and visit schedule;\n* Sign Informed Consent and privacy document;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Use of additional lens cleaners;\n* Known sensitivities to any ingredient in either test article;\n* Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;\n* History of ocular surgery/trauma within the last 6 months;\n* Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;\n* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01211535', 'briefTitle': 'Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers', 'orgStudyIdInfo': {'id': 'SMA-09-59'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OPTI-FREE RepleniSH', 'description': 'OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days', 'interventionNames': ['Device: OPTI-FREE RepleniSH multipurpose solution', 'Device: Silicone hydrogel contact lenses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ReNu Biotrue', 'description': 'ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days', 'interventionNames': ['Device: ReNu Biotrue multipurpose solution', 'Device: Silicone hydrogel contact lenses']}], 'interventions': [{'name': 'OPTI-FREE RepleniSH multipurpose solution', 'type': 'DEVICE', 'otherNames': ['OPTI-FREE® RepleniSH®'], 'description': 'FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days', 'armGroupLabels': ['OPTI-FREE RepleniSH']}, {'name': 'ReNu Biotrue multipurpose solution', 'type': 'DEVICE', 'otherNames': ['ReNu Biotrue™'], 'description': 'FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days', 'armGroupLabels': ['ReNu Biotrue']}, {'name': 'Silicone hydrogel contact lenses', 'type': 'DEVICE', 'description': "Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care", 'armGroupLabels': ['OPTI-FREE RepleniSH', 'ReNu Biotrue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Trial Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}