Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT03026257
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2017-01-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Assessment of a HYDRAGLYDE® Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Senior Clinical Project Lead, GCRA - Clin Dev Vision Care', 'organization': 'Alcon, A Novartis Division'}, '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': 'Lens insertion (Day 1) through study completion, an average of 30 days', 'description': 'Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all subjects/eyes exposed to study lens and/or study LCS evaluated in this study as a regimen (Safety Analysis Set). "At risk" population for ocular AEs is reported in units of eyes, as treated.', 'eventGroups': [{'id': 'EG000', 'title': 'AOHG/CCP Ocular', 'description': 'Eyes exposed to AOHG contact lenses and CCP for lens care', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 0, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AOHG/CCP Nonocular', 'description': 'Subjects exposed to AOHG contact lenses and CCP for lens care', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AOHG/OFPM Ocular', 'description': 'Eyes exposed to AOHG contact lenses and OFPM for lens care', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AOHG/OFPM Nonocular', 'description': 'Subjects exposed to AOHG contact lenses and OFPM for lens care', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Habitual SiHy/MPS Ocular', 'description': 'Eyes exposed to habitual SiHy contact lenses and habitual MPS for lens care', 'otherNumAtRisk': 258, 'deathsNumAtRisk': 258, 'otherNumAffected': 0, 'seriousNumAtRisk': 258, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Habitual SiHy/MPS Nonocular', 'description': 'Subjects exposed to habitual SiHy contact lenses and habitual MPS for lens care', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 0, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ex Vivo Total Cholesterol Uptake at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AOHG/CCP', 'description': 'Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent'}, {'id': 'OG001', 'title': 'AOHG/OFPM', 'description': 'Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent'}, {'id': 'OG002', 'title': 'Biofinity/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'OG003', 'title': 'Vita/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'OG004', 'title': 'Ultra/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'OG005', 'title': 'Oasys/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS"}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '2.17', 'spread': '1.47', 'groupId': 'OG002'}, {'value': '4.18', 'spread': '3.25', 'groupId': 'OG003'}, {'value': '2.07', 'spread': '1.48', 'groupId': 'OG004'}, {'value': '2.19', 'spread': '2.69', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG005'], 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG005'], 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.', 'unitOfMeasure': 'μg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set with cholesterol uptake measured'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AOHG/CCP', 'description': 'Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent'}, {'id': 'FG001', 'title': 'AOHG/OFPM', 'description': 'Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent'}, {'id': 'FG002', 'title': 'Biofinity/HMPS', 'description': "Habitual silicone hydrogel (SiHy) contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)"}, {'id': 'FG003', 'title': 'Vita/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'FG004', 'title': 'Ultra/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'FG005', 'title': 'Oasys/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized and treated, as randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '46'}]}, {'type': 'Treated', 'comment': 'Randomized and treated, as treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 8 study centers located in the United States (5), Germany (2), and Canada (1).', 'preAssignmentDetails': 'Of the 323 enrolled, 66 subjects exited as screen failures prior to randomization. An additional 5 subjects were randomized but discontinued prior to treatment. This reporting group includes all randomized and exposed subjects (252). Subject distribution in As Randomized and As Treatment differs due to 3 subjects with lens/solution misallocations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}, {'value': '252', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'AOHG/CCP', 'description': 'Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent'}, {'id': 'BG001', 'title': 'AOHG/OFPM', 'description': 'Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent'}, {'id': 'BG002', 'title': 'Biofinity/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'BG003', 'title': 'Vita/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'BG004', 'title': 'Ultra/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'BG005', 'title': 'Oasys/HMPS', 'description': "Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS"}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '27.8', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '28.2', 'spread': '5.9', 'groupId': 'BG002'}, {'value': '28.2', 'spread': '5.7', 'groupId': 'BG003'}, {'value': '28.8', 'spread': '7.2', 'groupId': 'BG004'}, {'value': '30.4', 'spread': '8.2', 'groupId': 'BG005'}, {'value': '28.4', 'spread': '6.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '179', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '73', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '238', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized and exposed to a study lens on Day 1 or a study regimen (lens and lens care system (LCS)) thereafter (Full Analysis Set).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-19', 'size': 2431087, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-20T13:31', 'hasProtocol': True}, {'date': '2017-01-24', 'size': 1236293, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-20T13:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-20', 'studyFirstSubmitDate': '2017-01-18', 'resultsFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-20', 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ex Vivo Total Cholesterol Uptake at Day 30', 'timeFrame': 'Day 30', 'description': 'The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Refractive Errors', 'Myopia', 'Hypermetropia']}, 'referencesModule': {'references': [{'pmid': '32769842', 'type': 'DERIVED', 'citation': 'Shows A, Redfern RL, Sickenberger W, Fogt JS, Schulze M, Lievens C, Szczotka-Flynn L, Schwarz S, Tichenor AA, Marx S, Lemp-Hull JM. Lipid Analysis on Block Copolymer-containing Packaging Solution and Lens Care Regimens: A Randomized Clinical Trial. Optom Vis Sci. 2020 Aug;97(8):565-572. doi: 10.1097/OPX.0000000000001553.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must sign informed consent document;\n* Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses;\n* Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add \\<+0.50 D in each eye;\n* Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available;\n* Current user of an MPS (excluding OFPM) to care for lenses;\n* Willing to answer text messages on a daily basis during the study;\n* Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits;\n* Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study;\n* Other protocol specific inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week);\n* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear;\n* History of herpetic keratitis, corneal surgery or irregular cornea;\n* Prior refractive surgery;\n* Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;\n* Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days;\n* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;\n* Monocular (only 1 eye with functional vision) or fit with only 1 lens;\n* Known pregnancy or lactating;\n* Other protocol specific exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03026257', 'briefTitle': 'Clinical Assessment of a HYDRAGLYDE® Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions', 'orgStudyIdInfo': {'id': 'LCW773-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AOHG', 'description': 'Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized', 'interventionNames': ['Device: Lotrafilcon B contact lenses with added wetting agent', 'Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent', 'Device: Hydrogen peroxide-based contact lens solution with added wetting agent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Habitual', 'description': "Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)", 'interventionNames': ['Device: Samfilcon A contact lenses', 'Device: Senofilcon C contact lenses', 'Device: Senofilcon A contact lenses', 'Device: Comfilcon A contact lenses', 'Device: Habitual Multi-Purpose Solution (HMPS)']}], 'interventions': [{'name': 'Lotrafilcon B contact lenses with added wetting agent', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® plus HYDRAGLYDE® (AOHG)'], 'description': 'Silicone hydrogel contact lenses', 'armGroupLabels': ['AOHG']}, {'name': 'Samfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['Bausch + Lomb ULTRA™ (Ultra)'], 'description': 'Habitual silicone hydrogel contact lenses', 'armGroupLabels': ['Habitual']}, {'name': 'POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent', 'type': 'DEVICE', 'otherNames': ['OPTI-FREE® PureMoist® (OFPM)'], 'description': 'Multi-purpose disinfecting solution for contact lens care', 'armGroupLabels': ['AOHG']}, {'name': 'Hydrogen peroxide-based contact lens solution with added wetting agent', 'type': 'DEVICE', 'otherNames': ['CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)'], 'description': 'Solution for contact lens cleaning and disinfecting', 'armGroupLabels': ['AOHG']}, {'name': 'Senofilcon C contact lenses', 'type': 'DEVICE', 'otherNames': ['Johnson & Johnson ACUVUE® VITA™ (Vita)'], 'description': 'Habitual silicone hydrogel contact lenses', 'armGroupLabels': ['Habitual']}, {'name': 'Senofilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)'], 'description': 'Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks', 'armGroupLabels': ['Habitual']}, {'name': 'Comfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['CooperVision® Biofinity® (Biofinity)'], 'description': 'Habitual silicone hydrogel contact lenses', 'armGroupLabels': ['Habitual']}, {'name': 'Habitual Multi-Purpose Solution (HMPS)', 'type': 'DEVICE', 'description': "Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions", 'armGroupLabels': ['Habitual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'N2L3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': '31134', 'city': 'Hildesheim', 'country': 'Germany', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': '07745', 'city': 'Jena', 'country': 'Germany', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Clinical Manager, Global Med Affairs, GCRA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon, A Novartis Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon, a Novartis Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}