Viewing Study NCT00727558


Ignite Creation Date: 2025-12-25 @ 12:09 AM
Ignite Modification Date: 2026-01-02 @ 2:01 AM
Study NCT ID: NCT00727558
Status: COMPLETED
Last Update Posted: 2015-05-21
First Post: 2008-07-30
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: A Comparison of Daily Disposable Contact Lenses.
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kmoody1@its.jnj.com', 'phone': '904-443-3088', 'title': 'Kurt Moody OD, FAAO/ Director', 'organization': 'Vistakon'}, 'certainAgreement': {'otherDetails': 'The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week', 'otherNumAtRisk': 127, 'otherNumAffected': 0, 'seriousNumAtRisk': 127, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week', 'otherNumAtRisk': 121, 'otherNumAffected': 0, 'seriousNumAtRisk': 121, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'OG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '3.903', 'spread': '0.1446', 'groupId': 'OG000'}, {'value': '3.349', 'spread': '0.1389', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '97.47', 'paramValue': '0.554', 'ciLowerLimit': '0.1721', 'ciUpperLimit': '0.554', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1943', 'estimateComment': 'The mean difference is narafilcon A minus nelfilcon A.', 'groupDescription': 'Alternative hypothesis: narafilcon A is superior to nelfilcon A', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1 week of wear.', 'description': 'Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the protocol and had no missing data (n=240)'}, {'type': 'PRIMARY', 'title': 'Measured Limbal Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'OG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.364', 'spread': '0.05494', 'groupId': 'OG000'}, {'value': '0.5374', 'spread': '0.0558', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '97.47', 'paramValue': '-0.1734', 'ciLowerLimit': '-0.1734', 'ciUpperLimit': '-0.1037', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03555', 'estimateComment': 'Mean difference is narafilcon A minus nelfilcon A', 'groupDescription': 'Alternative hypothesis: narafilcon A is superior to nelfilcon A.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1 week of wear.', 'description': 'Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol and had no missing data (n=243).'}, {'type': 'SECONDARY', 'title': 'Overall Handling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'OG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0959', 'spread': '0.1209', 'groupId': 'OG000'}, {'value': '3.6991', 'spread': '0.1172', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '98.7', 'paramValue': '0.3968', 'ciLowerLimit': '0.04983', 'ciUpperLimit': '0.3968', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1548', 'estimateComment': 'The mean difference is narafilcon A minus nelfilcon A.', 'groupDescription': 'Alternative hypothesis: narafilcon A is superior to nelfilcon A', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1 week of wear', 'description': 'Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol and had no missing data (n=240).'}, {'type': 'SECONDARY', 'title': 'How Comfortable Eyes Feel at the End of the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'OG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8669', 'spread': '0.1546', 'groupId': 'OG000'}, {'value': '3.4794', 'spread': '0.1487', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '98.7', 'paramValue': '0.3875', 'ciLowerLimit': '0.03714', 'ciUpperLimit': '0.3875', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2054', 'estimateComment': 'The mean difference is narafilcon A minus nelfilcon A.', 'groupDescription': 'Alternative hypothesis: narafilcon A is superior to nelfilcon A.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1 week wear', 'description': 'Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol and had no missing data.'}, {'type': 'SECONDARY', 'title': 'End of Day Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'OG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '3.425', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '2.7515', 'spread': '0.1269', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '98.7', 'paramValue': '0.6735', 'ciLowerLimit': '0.213', 'ciUpperLimit': '0.6735', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1563', 'estimateComment': 'The mean difference is narafilcon A minus nelfilcon A.', 'groupDescription': 'Alternative hypothesis: narafilcon A is superior to nelfilcon A', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1 week of wear', 'description': 'Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol and had no missing data (n=240).'}, {'type': 'SECONDARY', 'title': 'Initial Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'OG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0306', 'spread': '0.1352', 'groupId': 'OG000'}, {'value': '3.8986', 'spread': '0.1312', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '98.7', 'paramValue': '0.132', 'ciLowerLimit': '-0.2375', 'ciUpperLimit': '0.132', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1648', 'estimateComment': 'Mean difference is narafilcon A minus nelfilcon A.', 'groupDescription': 'Alternative hypothesis: narafilcon A is superior to nelfilcon A', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1 week', 'description': 'Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol and had no missing data (n=240).'}, {'type': 'SECONDARY', 'title': 'Inferior Region Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'OG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.311', 'spread': '0.03884', 'groupId': 'OG000'}, {'value': '0.5579', 'spread': '0.03974', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '97.47', 'paramValue': '-0.2469', 'ciLowerLimit': '-0.2469', 'ciUpperLimit': '-0.1599', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04448', 'estimateComment': 'The mean difference is narafilcon A minus nelfilcon A.', 'groupDescription': 'Alternative hypothesis: narafilcon A is superior to nelfilcon A by having a lower level of inferior region corneal staining', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 1 week of wear', 'description': 'National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol and had no missing data (n=243).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'FG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lens issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject unable to return for follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Narafilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'BG001', 'title': 'Nelfilcon A', 'description': 'soft contact lens worn as a daily disposable modality for one week'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '32.9', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Includes completed subjects only', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Includes completed subjects only', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Includes completed subjects only', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2008-07-30', 'resultsFirstSubmitDate': '2009-09-24', 'studyFirstSubmitQcDate': '2008-08-01', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-28', 'studyFirstPostDateStruct': {'date': '2008-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Comfort', 'timeFrame': 'at 1 week of wear.', 'description': 'Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent'}, {'measure': 'Measured Limbal Hyperemia', 'timeFrame': 'at 1 week of wear.', 'description': 'Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.'}], 'secondaryOutcomes': [{'measure': 'Overall Handling', 'timeFrame': 'at 1 week of wear', 'description': 'Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.'}, {'measure': 'How Comfortable Eyes Feel at the End of the Day', 'timeFrame': 'at 1 week wear', 'description': 'Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.'}, {'measure': 'End of Day Comfort', 'timeFrame': 'at 1 week of wear', 'description': 'Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent'}, {'measure': 'Initial Comfort', 'timeFrame': 'at 1 week', 'description': 'Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.'}, {'measure': 'Inferior Region Corneal Staining', 'timeFrame': 'at 1 week of wear', 'description': 'National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.'}]}, 'conditionsModule': {'keywords': ['refractive error'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* They are of legal age (18 years) and capacity to volunteer.\n* They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.\n* They are willing and able to follow the protocol.\n* They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.\n* They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.\n* They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).\n* They have successfully worn contact lenses within six months of starting the study.\n\nExclusion Criteria:\n\n* They have an ocular disorder which would normally contra-indicate contact lens wear.\n* They have a systemic disorder which would normally contra-indicate contact lens wear.\n* They are using any topical medication such as eye drops or ointment.\n* They are aphakic.\n* They have had corneal refractive surgery.\n* They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.\n* They are pregnant or lactating.\n* They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.\n* They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).\n* They have diabetes.\n* They have taken part in any other clinical trial or research, within two weeks prior to starting this study.'}, 'identificationModule': {'nctId': 'NCT00727558', 'briefTitle': 'A Comparison of Daily Disposable Contact Lenses.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-0808'}, 'secondaryIdInfos': [{'id': 'PROD-501'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'narafilcon A', 'description': 'spherical soft contact lens worn as a daily disposable modality for one week', 'interventionNames': ['Device: narafilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nelfilcon A', 'description': 'spherical soft contact lens worn as a daily disposable modality for one week', 'interventionNames': ['Device: nelfilcon A', 'Device: narafilcon A']}], 'interventions': [{'name': 'nelfilcon A', 'type': 'DEVICE', 'description': 'spherical soft contact lens', 'armGroupLabels': ['nelfilcon A']}, {'name': 'narafilcon A', 'type': 'DEVICE', 'description': 'spherical soft contact lens', 'armGroupLabels': ['narafilcon A', 'nelfilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA1 1BA', 'city': 'Bath', 'state': 'Bath', 'country': 'United Kingdom', 'facility': 'Ellis & Killpartrick', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'MK40 1NS', 'city': 'Bedford', 'state': 'Bedfordshire', 'country': 'United Kingdom', 'facility': 'Simon Donne Opticians 3-4', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}, {'zip': 'BS4 3LJ', 'city': 'Brislington', 'state': 'Bristol', 'country': 'United Kingdom', 'facility': 'Brock & Houlford', 'geoPoint': {'lat': 51.43351, 'lon': -2.54721}}, {'zip': 'PL1 1LB', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'The Contact Lens Centre', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'BH18 8DH', 'city': 'Broadstone', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Keith Tempany Opticians', 'geoPoint': {'lat': 50.75717, 'lon': -1.99406}}, {'zip': 'IG1 4DU', 'city': 'Ilford', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Eyecare', 'geoPoint': {'lat': 51.55765, 'lon': 0.07278}}, {'zip': 'AL1 3LH', 'city': 'Albans', 'state': 'Herts', 'country': 'United Kingdom', 'facility': 'Leightons Opticians'}, {'zip': 'PO37 6JZ', 'city': 'Shanklin', 'state': 'Isle of Wight', 'country': 'United Kingdom', 'facility': 'Hazel Smith Opticians', 'geoPoint': {'lat': 50.62613, 'lon': -1.1785}}, {'zip': 'ME7 2YX', 'city': 'Gillingham', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Bowden & Lowe', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}, {'zip': 'BB4 7QN', 'city': 'Rawtenstall', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'David Gould Opticians', 'geoPoint': {'lat': 53.70076, 'lon': -2.28442}}, {'zip': 'NW4 3FB', 'city': 'Hendon', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Vision Express Optical Lab', 'geoPoint': {'lat': 51.6, 'lon': -0.21667}}, {'zip': 'EC3V 1LT', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Hawkes & Wainer', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC2A 1AA', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'City Opticians', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'N17 0EY', 'city': 'Tottenham', 'state': 'London', 'country': 'United Kingdom', 'facility': 'David H Burns BSC, FCOptom', 'geoPoint': {'lat': 51.60373, 'lon': -0.06794}}, {'zip': 'HA5 1RJ', 'city': 'Eastcote Pinner', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'First Contact Opticians'}, {'zip': 'NN2 7BL', 'city': 'Northampton', 'state': 'Northampton', 'country': 'United Kingdom', 'facility': 'Tompkins Knight & Son', 'geoPoint': {'lat': 52.25, 'lon': -0.88333}}, {'zip': 'CF24 3RQ', 'city': 'Cardiff', 'state': 'South Glamorgan', 'country': 'United Kingdom', 'facility': 'Chalmers & Son (Opticians)', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CV4 9DU', 'city': 'Coventry', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Susan R Bowers Opticians', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'YO1 8BA', 'city': 'York', 'state': 'York', 'country': 'United Kingdom', 'facility': 'Viewpoint', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Visioncare Research Ltd.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}