Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT02956460
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance Comparison Between Fanfilcon A and Senofilcon A Sphere 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': 'JVega2@coopervision.com', 'phone': '925-621-3761', 'title': 'Jose Vega, O.D., MSc., FAAO', 'organization': 'CooperVision'}, 'certainAgreement': {'otherDetails': 'Disclosure restriction on the PI is that the sponsor should be notified of any use of study data for results communication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the 2 week period for each lens', 'eventGroups': [{'id': 'EG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': "Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vision Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Handling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'title': 'Insertion', 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Removal', 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vision Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'title': 'Optimum', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Acceptable', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unacceptable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Conjunctival Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.\n\n0=None, no staining present\n\n1. Very slight\n2. Slight\n3. Moderate\n4. Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Smoothness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clean Feeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Hydrated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fanfilcon A First Then Senofilcon A', 'description': 'Participants are randomized to wear fanfilcon A for two weeks then senofilcon A'}, {'id': 'FG001', 'title': 'Senofilcon A First Then Fanfilcon A', 'description': 'Participants are randomized to wear senofilcon A for two weeks then fanfilcon A'}], 'periods': [{'title': 'Lens 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Lens 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fanfilcon A First Then Senofilcon A', 'description': 'Participants are randomized to wear fanfilcon A for two weeks then senofilcon A'}, {'id': 'BG001', 'title': 'Senofilcon A First Then Fanfilcon A', 'description': 'Participants are randomized to wear senofilcon A for two weeks then fanfilcon A'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '29.6', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '30.5', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2016-11-03', 'resultsFirstSubmitDate': '2017-11-10', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-10', 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Comfort', 'timeFrame': '2 weeks', 'description': "Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel"}, {'measure': 'Overall Dryness', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness'}, {'measure': 'Vision Quality', 'timeFrame': '2 weeks', 'description': 'Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear'}, {'measure': 'Lens Handling', 'timeFrame': '2 weeks', 'description': 'Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle'}, {'measure': 'Vision Satisfaction', 'timeFrame': '2 weeks', 'description': 'Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.'}, {'measure': 'Lens Centration', 'timeFrame': '2 weeks', 'description': 'Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).'}, {'measure': 'Conjunctival Staining', 'timeFrame': '2 weeks', 'description': 'Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.\n\n0=None, no staining present\n\n1. Very slight\n2. Slight\n3. Moderate\n4. Severe'}, {'measure': 'Smoothness', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth'}, {'measure': 'Clean Feeling', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean'}, {'measure': 'Lens Hydrated', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated'}, {'measure': 'Lens Wettability', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)', 'detailedDescription': 'The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA person is eligible for inclusion in the study if he/she:\n\n* Is between 18 and 40 years of age (inclusive)\n* Has read, understood and signed the information consent letter\n* Has had a self-reported eye exam in the last two years\n* Is a spherical soft contact lens wearer\n* Has a contact lens prescription that fits within the available parameters of the study lenses\n* Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye\n* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye\n* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses\n* Has clear corneas and no active ocular disease\n* Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)\n* Is willing and able to follow instructions and maintain the appointment schedule\n\nExclusion Criteria:\n\nA person will be excluded from the study if he/she:\n\n* Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; \\>8 hours/day)\n* Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses\n* Is habitually using rewetting/ lubricating eye drops more than once per day\n* Presents with clinically significant anterior segment abnormalities\n* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear\n* Presents with slit lamp findings that would contraindicate contact lens wear such as:\n\n * Pathological dry eye or associated findings\n * Significant 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 (or history in past year)\n * Seborrheic eczema of eyelid region, 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'}, 'identificationModule': {'nctId': 'NCT02956460', 'briefTitle': 'Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-73'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fanfilcon A', 'description': 'Participants are randomized to wear fanfilcon A for two weeks during the cross over study.', 'interventionNames': ['Device: fanfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'senofilcon A', 'description': 'Participants are randomized to wear senofilcon A for two weeks during the cross over study.', 'interventionNames': ['Device: senofilcon A']}], 'interventions': [{'name': 'fanfilcon A', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['fanfilcon A']}, {'name': 'senofilcon A', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['senofilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Eric M. White O. D., Inc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Golden Vision', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kannarr Eye Care', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Nittany Eye Associates', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD, FAAO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre for Contact Lens Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}