Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-27 @ 4:13 PM
Study NCT ID:
NCT02299869
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2014-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
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': 'javega@coopervision.com', 'phone': '(925) 621-3761', 'title': 'Sr. Manager Global Medical Scientific Affairs', 'organization': 'CooperVision'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Overall Participants', 'description': 'Each subject was randomized to wear the test and control lenses in a series of four short fitting comparisons (pair 1, pair 2, pair 3, and pair 4).', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cosmetic Appearance Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Verde (Competitor-control) vs. Green (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG001', 'title': 'Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG002', 'title': 'Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG003', 'title': 'Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}], 'classes': [{'title': 'Competitor-control lens', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'CVI-test lens', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '20 minutes', 'description': "Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Verde (Competitor-control) vs. Green (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG001', 'title': 'Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG002', 'title': 'Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG003', 'title': 'Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}], 'classes': [{'title': 'Competitor-control lens', 'categories': [{'measurements': [{'value': '8.6', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '7.1', 'spread': '2.2', 'groupId': 'OG003'}]}]}, {'title': 'CVI-test lens', 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '8.0', 'spread': '2.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Verde (Competitor-control) vs. Green (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG001', 'title': 'Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG002', 'title': 'Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG003', 'title': 'Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}], 'classes': [{'title': 'Competitor control lens', 'categories': [{'measurements': [{'value': '9.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '8.6', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'CVI-test lens', 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '8.8', 'spread': '1.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': "Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comfort Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Verde (Competitor-control) vs. Green (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG001', 'title': 'Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG002', 'title': 'Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG003', 'title': 'Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}], 'classes': [{'title': 'Competitor-control lens', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'CVI-test lens', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comfort Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Verde (Competitor-control) vs. Green (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG001', 'title': 'Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG002', 'title': 'Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'OG003', 'title': 'Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}], 'classes': [{'title': 'Competitor-control lens', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'CVI-test lens', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '20 minutes', 'description': "Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 - Verde (Competitor-control) vs. Green (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'FG001', 'title': 'Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'FG002', 'title': 'Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'FG003', 'title': 'Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One participant was disqualified from the study due to not meeting inclusion criteria before lens dispensing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 - Verde (Competitor-control) vs. Green (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'BG001', 'title': 'Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'BG002', 'title': 'Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'BG003', 'title': 'Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '21.8', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '20.7', 'spread': '2.4', 'groupId': 'BG002'}, {'value': '20.9', 'spread': '1.9', 'groupId': 'BG003'}, {'value': '21.2', 'spread': '2.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2014-11-20', 'resultsFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2014-11-21', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-22', 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmetic Appearance Preference', 'timeFrame': '20 minutes', 'description': "Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference"}, {'measure': 'Comfort', 'timeFrame': 'Baseline', 'description': "Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent)."}, {'measure': 'Comfort', 'timeFrame': '20 minutes', 'description': "Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent)."}, {'measure': 'Comfort Preference', 'timeFrame': 'Baseline', 'description': "Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference"}, {'measure': 'Comfort Preference', 'timeFrame': '20 minutes', 'description': "Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses', 'detailedDescription': 'Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the test and control lenses in a series of four short fitting comparisons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is between 18 and 40 years of age (inclusive).\n* Has had a self-reported visual exam in the last two years.\n* Is an adapted wearer of spherical soft contact lenses.\n* Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive).\n* Has a spectacle cylinder up to 0.75 diopter (D) in each eye\n* Can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.\n* Has clear corneas and no active ocular disease.\n* Has read, understood and signed the information consent letter.\n* Is willing to wear his/hers spectacles over the study contact lenses.\n* Is willing to comply with the wear schedule.\n* Is willing to comply with the visit schedule.\n\nExclusion Criteria:\n\n* Has never worn contact lenses before.\n* Currently wears rigid gas permeable contact lenses.\n* Has a history of not achieving comfortable contact lens wear (5 days per week; \\> 8 hours/day)\n* Has a contact lens prescription outside the range of - 1.00 to -10.00D.\n* Has a spectacle cylinder ≥1.00D of cylinder in either eye.\n* Does not have a pair of corrective spectacles at the time of the visit.\n* Cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.\n* Presence of clinically significant (grade \\> 2.0, scale 0-4) anterior segment abnormalities.\n* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.\n* Slit lamp findings that would contraindicate contact lens wear such as:\n\n * Pathological dry eye or associated findings\n * Pterygium, pinguecula, or corneal scars within the visual axis\n * Neovascularization \\> 0.75 mm in from of the limbus\n * Giant papillary conjunctivitis (GCP) worse than grade 1\n * Anterior uveitis or iritis (past or present)\n * Seborrheic eczema, Seborrheic conjunctivitis\n * History of corneal ulcers or fungal infections\n * Poor personal hygiene\n* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)\n* Has aphakia, keratoconus or a highly irregular cornea.\n* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT02299869', 'briefTitle': 'Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.', 'orgStudyIdInfo': {'id': 'EX-MKTG-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1 - Verde (Competitor-control) vs. Green (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.', 'interventionNames': ['Device: Verde (Competitor-control)', 'Device: Green (CVI-test)']}, {'type': 'OTHER', 'label': 'Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.', 'interventionNames': ['Device: Cinza (Competitor-control)', 'Device: Grey (CVI-test)']}, {'type': 'OTHER', 'label': 'Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.', 'interventionNames': ['Device: Esmeralda (Competitor-control)', 'Device: Jade (CVI-test)']}, {'type': 'OTHER', 'label': 'Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)', 'description': 'Each subject was randomized to wear the test and control lenses contralaterally.', 'interventionNames': ['Device: Azul (Competitor-control)', 'Device: Blue (CVI-test)']}], 'interventions': [{'name': 'Verde (Competitor-control)', 'type': 'DEVICE', 'otherNames': ['methafilcon A'], 'description': 'contact lens', 'armGroupLabels': ['Group 1 - Verde (Competitor-control) vs. Green (CVI-test)']}, {'name': 'Green (CVI-test)', 'type': 'DEVICE', 'otherNames': ['methafilcon A'], 'description': 'contact lens', 'armGroupLabels': ['Group 1 - Verde (Competitor-control) vs. Green (CVI-test)']}, {'name': 'Cinza (Competitor-control)', 'type': 'DEVICE', 'otherNames': ['methafilcon A'], 'description': 'contact lens', 'armGroupLabels': ['Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)']}, {'name': 'Grey (CVI-test)', 'type': 'DEVICE', 'otherNames': ['methafilcon A'], 'description': 'contact lens', 'armGroupLabels': ['Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)']}, {'name': 'Esmeralda (Competitor-control)', 'type': 'DEVICE', 'otherNames': ['methafilcon A'], 'description': 'contact lens', 'armGroupLabels': ['Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)']}, {'name': 'Jade (CVI-test)', 'type': 'DEVICE', 'otherNames': ['methafilcon A'], 'description': 'contact lens', 'armGroupLabels': ['Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)']}, {'name': 'Azul (Competitor-control)', 'type': 'DEVICE', 'otherNames': ['methafilcon A'], 'description': 'contact lens', 'armGroupLabels': ['Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)']}, {'name': 'Blue (CVI-test)', 'type': 'DEVICE', 'otherNames': ['methafilcon A'], 'description': 'contact lens', 'armGroupLabels': ['Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Optometry Clinic, National Autonomous University', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Ruben Velazquez Guerrero, MSc FIACLE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Optometry, National Autonomous University (UNAM), Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}