Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-04-16 @ 10:35 PM
Study NCT ID:
NCT02413333
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2015-04-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clear Care® Plus vs. PeroxiClear™
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Global Medical Affairs Franchise Head, Vision Care', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected for the duration of the study from the signing of informed consent (up to 60 [+10] days).', 'description': 'AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs, whether or not related to the medical device, obtained through solicited and spontaneous comments from all exposed participants and reported based on the treatment received. Ocular AEs are presented for both eyes combined.', 'eventGroups': [{'id': 'EG000', 'title': 'PeroxiClear', 'description': 'While using PeroxiClear', 'otherNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clear Care Plus', 'description': 'While using Clear Care Plus', 'otherNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Residual Peroxide at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}, {'units': 'Lens Cases', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PeroxiClear', 'description': 'PeroxiClear Lens Cases'}, {'id': 'OG001', 'title': 'Clear Care Plus', 'description': 'Clear Care Plus Lens Cases'}], 'classes': [{'categories': [{'measurements': [{'value': '229.7', 'spread': '280.13', 'groupId': 'OG000'}, {'value': '26.2', 'spread': '41.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30, each product', 'description': 'The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).', 'unitOfMeasure': 'parts per million (ppm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lens Cases', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Intention to treat participants with non-missing observations'}, {'type': 'SECONDARY', 'title': 'Mean Osmolality in Lens Cases at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}, {'units': 'Lens Cases', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PeroxiClear', 'description': 'PeroxiClear Lens Cases'}, {'id': 'OG001', 'title': 'Clear Care Plus', 'description': 'Clear Care Plus Lens Cases'}], 'classes': [{'categories': [{'measurements': [{'value': '345.1', 'spread': '11.76', 'groupId': 'OG000'}, {'value': '299.2', 'spread': '7.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30, each product', 'description': 'The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).', 'unitOfMeasure': 'milliosmoles/kg (mOsm/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lens Cases', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Intention to treat participants with non-missing observations'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clear Care Plus, Then PeroxiClear', 'description': "Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles."}, {'id': 'FG001', 'title': 'PeroxiClear, Then Clear Care Plus', 'description': "PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles."}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Randomized and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from ten investigational centers located in the United States.', 'preAssignmentDetails': 'All randomized participants (132). One enrolled participant discontinued prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Clear Care Plus, Then PeroxiClear', 'description': 'Clear Care Plus was used in Period 1, then PeroxiClear in Period 2.'}, {'id': 'BG001', 'title': 'PeroxiClear, Then Clear Care Plus', 'description': 'PeroxiClear was used in Period 1, then Clear Care Plus in Period 2.'}, {'id': 'BG002', 'title': 'Clear Care Plus, Then Clear Care Plus', 'description': 'Clear Care Plus was used in Period 1 and in Period 2.'}, {'id': 'BG003', 'title': 'PeroxiClear, Then PeroxiClear', 'description': 'PeroxiClear was used in Period 1 and in Period 2.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '35.7', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '42.0', 'spread': 'NA', 'comment': 'Single data point', 'groupId': 'BG002'}, {'value': '38.0', 'spread': 'NA', 'comment': 'Single data point', 'groupId': 'BG003'}, {'value': '36.7', 'spread': '11.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-64 years', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set, defined as all participants randomized and treated. Two participants inadvertently used the incorrect product during the second period, and they are defined according to the treatment received.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2015-04-07', 'resultsFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2015-04-07', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-29', 'studyFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Residual Peroxide at Day 30', 'timeFrame': 'Day 30, each product', 'description': 'The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).'}], 'secondaryOutcomes': [{'measure': 'Mean Osmolality in Lens Cases at Day 30', 'timeFrame': 'Day 30, each product', 'description': 'The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lens solution'], 'conditions': ['Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.', 'detailedDescription': 'Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign informed consent form;\n* Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);\n* Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;\n* Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Current hydrogen peroxide-based solution user;\n* Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;\n* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;\n* Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;\n* Use of systemic or ocular medications for which contact lens wear could be contraindicated;\n* Monocular (only 1 eye with functional vision) or fit with only 1 lens;\n* History of herpetic keratitis, ocular surgery, or irregular cornea;\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02413333', 'briefTitle': 'Clear Care® Plus vs. PeroxiClear™', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers', 'orgStudyIdInfo': {'id': 'LCD913-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clear Care Plus, then PeroxiClear', 'description': "Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.", 'interventionNames': ['Device: Clear Care Plus contact lens solution', 'Device: PeroxiClear contact lens solution', 'Device: Silicone hydrogel contact lenses']}, {'type': 'OTHER', 'label': 'PeroxiClear, then Clear Care Plus', 'description': "PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.", 'interventionNames': ['Device: Clear Care Plus contact lens solution', 'Device: PeroxiClear contact lens solution', 'Device: Silicone hydrogel contact lenses']}], 'interventions': [{'name': 'Clear Care Plus contact lens solution', 'type': 'DEVICE', 'otherNames': ['Clear Care Plus'], 'description': '3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses', 'armGroupLabels': ['Clear Care Plus, then PeroxiClear', 'PeroxiClear, then Clear Care Plus']}, {'name': 'PeroxiClear contact lens solution', 'type': 'DEVICE', 'otherNames': ['PeroxiClear'], 'description': '3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses', 'armGroupLabels': ['Clear Care Plus, then PeroxiClear', 'PeroxiClear, then Clear Care Plus']}, {'name': 'Silicone hydrogel contact lenses', 'type': 'DEVICE', 'description': "2-week/monthly replacement contact lenses per participant's habitual brand", 'armGroupLabels': ['Clear Care Plus, then PeroxiClear', 'PeroxiClear, then Clear Care Plus']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Manager, Vision Care, Global Medical Affairs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}