Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-28 @ 1:11 PM
Study NCT ID:
NCT01699750
Status:
COMPLETED
Last Update Posted:
2014-12-08
First Post:
2012-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
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': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Jessie Lemp, DrPH', '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 were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study.', 'description': 'An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.', 'eventGroups': [{'id': 'EG000', 'title': 'AIR OPTIX AQUA', 'description': 'Lotrafilcon B contact lenses worn for 60 days, replaced monthly', 'otherNumAtRisk': 34, 'otherNumAffected': 3, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ACUVUE OASYS With HYDRACLEAR', 'description': 'Senofilcon A contact lenses worn for 60 days, replaced biweekly', 'otherNumAtRisk': 36, 'otherNumAffected': 7, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eye complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Ex-Vivo Total Lipid Uptake Per Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Optix Aqua', 'description': 'Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each'}, {'id': 'OG001', 'title': 'Acuvue Oasys', 'description': 'Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each'}], 'classes': [{'categories': [{'measurements': [{'value': '7.198', 'spread': '1.5014', 'groupId': 'OG000'}, {'value': '35.879', 'spread': '1.8185', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.', 'unitOfMeasure': 'micrograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Optix Aqua', 'description': 'Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each'}, {'id': 'OG001', 'title': 'Acuvue Oasys', 'description': 'Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each'}], 'classes': [{'categories': [{'measurements': [{'value': '3.316', 'spread': '2.6913', 'groupId': 'OG000'}, {'value': '2.918', 'spread': '2.4859', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.'}, {'type': 'SECONDARY', 'title': 'LogMAR Time-Controlled Visual Acuity (TCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Optix Aqua', 'description': 'Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each'}, {'id': 'OG001', 'title': 'Acuvue Oasys', 'description': 'Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each'}], 'classes': [{'title': 'High Contrast', 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.058', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.999', 'groupId': 'OG001'}]}]}, {'title': 'Low Contrast', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.213', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '1.040', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.', 'unitOfMeasure': 'VA unit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Comfort Measured With Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OFPM With Air Optix Aqua', 'description': 'OFPM with lotrafilcon B contact lenses for 30 days'}, {'id': 'OG001', 'title': 'OFPM With Acuvue Oasys', 'description': 'OFPM with senofilcon A contact lenses for 30 days'}, {'id': 'OG002', 'title': 'BIOTRUE With Air Optix Aqua', 'description': 'BIOTRUE with lotrafilcon B contact lenses for 30 days'}, {'id': 'OG003', 'title': 'BIOTRUE With Acuvue Oasys', 'description': 'BIOTRUE with senofilcon A contact lenses for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'spread': '20.25', 'groupId': 'OG000'}, {'value': '81.1', 'spread': '20.37', 'groupId': 'OG001'}, {'value': '74.9', 'spread': '28.43', 'groupId': 'OG002'}, {'value': '82.2', 'spread': '20.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Overall Dryness Measured With Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OFPM With Air Optix Aqua', 'description': 'OFPM with lotrafilcon B contact lenses for 30 days'}, {'id': 'OG001', 'title': 'OFPM With Acuvue Oasys', 'description': 'OFPM with senofilcon A contact lenses for 30 days'}, {'id': 'OG002', 'title': 'BIOTRUE With Air Optix Aqua', 'description': 'BIOTRUE with lotrafilcon B contact lenses for 30 days'}, {'id': 'OG003', 'title': 'BIOTRUE With Acuvue Oasys', 'description': 'BIOTRUE with senofilcon A contact lenses for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '20.41', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '22.15', 'groupId': 'OG001'}, {'value': '23.3', 'spread': '25.65', 'groupId': 'OG002'}, {'value': '22.5', 'spread': '25.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Average Exposure Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Optix Aqua', 'description': 'Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each'}, {'id': 'OG001', 'title': 'Acuvue Oasys', 'description': 'Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each'}], 'classes': [{'categories': [{'measurements': [{'value': '0.059', 'spread': '15.1175', 'groupId': 'OG000'}, {'value': '0.105', 'spread': '24.4808', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.', 'unitOfMeasure': 'percent of area exposed/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.'}, {'type': 'SECONDARY', 'title': 'Minimum Protected Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Optix Aqua', 'description': 'Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each'}, {'id': 'OG001', 'title': 'Acuvue Oasys', 'description': 'Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each'}], 'classes': [{'categories': [{'measurements': [{'value': '90.75', 'spread': '15.990', 'groupId': 'OG000'}, {'value': '77.79', 'spread': '31.547', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.', 'unitOfMeasure': 'percentage of lens surface covered', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Air Optix Aqua', 'description': 'Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each'}, {'id': 'FG001', 'title': 'Acuvue Oasys', 'description': 'Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from 1 study center located in the United Kingdom.', 'preAssignmentDetails': 'Of the 109 participants enrolled, 39 were exited from the study prior to randomization and product dispense (Phase 2). This reporting group includes all randomized and dispensed participants (70).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Air Optix Aqua', 'description': 'Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each'}, {'id': 'BG001', 'title': 'Acuvue Oasys', 'description': 'Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'spread': '10.95', 'groupId': 'BG000'}, {'value': '35.3', 'spread': '8.77', 'groupId': 'BG001'}, {'value': '35.6', 'spread': '9.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized and dispensed participants.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2012-10-02', 'resultsFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-03', 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Ex-Vivo Total Lipid Uptake Per Lens', 'timeFrame': 'Day 30', 'description': 'The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.'}], 'secondaryOutcomes': [{'measure': 'Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)', 'timeFrame': 'Day 30', 'description': 'The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.'}, {'measure': 'LogMAR Time-Controlled Visual Acuity (TCVA)', 'timeFrame': 'Day 30', 'description': 'Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.'}, {'measure': 'Overall Comfort Measured With Visual Analog Scale (VAS)', 'timeFrame': 'Day 30', 'description': 'The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.'}, {'measure': 'Overall Dryness Measured With Visual Analog Scale (VAS)', 'timeFrame': 'Day 30', 'description': 'The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.'}, {'measure': 'Average Exposure Speed', 'timeFrame': 'Day 30', 'description': 'Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.'}, {'measure': 'Minimum Protected Area', 'timeFrame': 'Day 30', 'description': 'Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contact lenses', 'contact lens solution', 'myopia', 'astigmatism'], 'conditions': ['Myopia', 'Astigmatism', 'Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.', 'detailedDescription': 'This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Read and understand the Participant Information Sheet;\n* Read, sign, and date the Informed Consent;\n* Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;\n* Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;\n* Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;\n* Best corrected visual acuity of 6/9 or better in each eye;\n* Normal eyes with the exception of the need for visual correction;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;\n* Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);\n* Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;\n* Systemic disease which might interfere with contact lens wear or produce dry eye side effects;\n* Systemic or ocular allergies which might interfere with contact lens wear;\n* Ocular disease which might interfere with contact lens wear;\n* Active ocular infection;\n* Use of any concomitant topical ocular medications during the study period;\n* Previous ocular surgery;\n* Pregnant, planning to become pregnant, or lactating at the time of enrollment;\n* Participation in an investigational drug or device study within 30 days of entering this study;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01699750', 'briefTitle': 'Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems', 'orgStudyIdInfo': {'id': 'M-12-043 / ID11-59'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Air Optix Aqua', 'description': 'Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each', 'interventionNames': ['Device: Lotrafilcon B contact lenses', 'Device: OPTI-FREE® PUREMOIST® MPDS', 'Device: BIOTRUE®', 'Device: Balafilcon A contact lenses', 'Device: ReNu® Multiplus®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acuvue Oasys', 'description': 'Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each', 'interventionNames': ['Device: Senofilcon A contact lenses', 'Device: OPTI-FREE® PUREMOIST® MPDS', 'Device: BIOTRUE®', 'Device: Balafilcon A contact lenses', 'Device: ReNu® Multiplus®']}], 'interventions': [{'name': 'Lotrafilcon B contact lenses', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® AQUA', 'AOA'], 'description': 'Silicone hydrogel contact lenses, Phase 2', 'armGroupLabels': ['Air Optix Aqua']}, {'name': 'Senofilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['ACUVUE® OASYS® with HYDRACLEAR®', 'AVO'], 'description': 'Silicone hydrogel contact lenses, Phase 2', 'armGroupLabels': ['Acuvue Oasys']}, {'name': 'OPTI-FREE® PUREMOIST® MPDS', 'type': 'DEVICE', 'otherNames': ['OFPM'], 'description': 'Contact lens care system, Phase 2', 'armGroupLabels': ['Acuvue Oasys', 'Air Optix Aqua']}, {'name': 'BIOTRUE®', 'type': 'DEVICE', 'description': 'Contact lens care system, Phase 2', 'armGroupLabels': ['Acuvue Oasys', 'Air Optix Aqua']}, {'name': 'Balafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['PureVision'], 'description': 'Silicone hydrogel contact lenses worn for 30 days, Phase 1', 'armGroupLabels': ['Acuvue Oasys', 'Air Optix Aqua']}, {'name': 'ReNu® Multiplus®', 'type': 'DEVICE', 'description': 'Contact lens care system used for 30 days, Phase 1', 'armGroupLabels': ['Acuvue Oasys', 'Air Optix Aqua']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center at 1-888-451-3937 for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Jami Kern, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}