Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-29 @ 11:55 AM
Study NCT ID:
NCT00708032
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2008-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalstudies@its.jnj.com', 'phone': '+1 904 443-1032', 'title': 'Kathy Osborn, OD', 'organization': 'Johnson & Johnson Vision Care, Inc.'}, 'certainAgreement': {'otherDetails': 'Publication requires agreement and written consent from the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the entire duration of the sutdy. Approximately 12 month.', 'eventGroups': [{'id': 'EG000', 'title': 'Spectacles', 'description': 'spectacles worn daily for 12 months', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 5, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Narafilcon A Lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 4, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Non-signficant Corneal Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 27, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A Lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months'}, {'id': 'OG001', 'title': 'Spectacles', 'description': 'habitual spectacles worn daily for 12 months'}], 'classes': [{'title': 'Conjunctival Hyperemia', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Limbal Hyperemia', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Vascularization', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Microcysts', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Oedema', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Corneal Staining', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctival Staining', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12 months', 'description': 'Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.'}, {'type': 'SECONDARY', 'title': 'Visual Acuity After 12 Months of Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A Lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months'}, {'id': 'OG001', 'title': 'Spectacles', 'description': 'habitual spectacles worn daily for 12 months'}], 'classes': [{'title': 'High Contrast', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Low Contrast', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12 months', 'description': 'Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.', 'unitOfMeasure': 'logMar', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.'}, {'type': 'SECONDARY', 'title': 'Subjective Overall Comfort After 12 Months of Daily Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A Lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months'}, {'id': 'OG001', 'title': 'Spectacles', 'description': 'habitual spectacles worn daily for 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '87.8', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '82.2', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12 months', 'description': 'subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.'}, {'type': 'SECONDARY', 'title': 'Subjective Overall Vision After 12 Months of Daily Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A Lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months'}, {'id': 'OG001', 'title': 'Spectacles', 'description': 'habitual spectacles worn daily for 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '88.7', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12 months', 'description': 'subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.'}, {'type': 'PRIMARY', 'title': 'Papillary Conjunctivitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon A Lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months'}, {'id': 'OG001', 'title': 'Spectacles', 'description': 'habitual spectacles worn daily for 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spectacles', 'description': 'spectacles worn daily for 12 months'}, {'id': 'FG001', 'title': 'Narafilcon A Lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor vision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Visit out of range at month 12', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not meet protocol criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'There were 74 subjects enrolled into the study, 38 into the TruEye group and 36 in the spectacle group. Forty-eight subjects completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Spectacles', 'description': 'spectacles worn daily for 12 months'}, {'id': 'BG001', 'title': 'Narafilcon A Lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '26.5', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There were 74 subjects enrolled with 48 completing the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2008-06-27', 'resultsFirstSubmitDate': '2011-11-03', 'studyFirstSubmitQcDate': '2008-06-27', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-11-03', 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Papillary Conjunctivitis', 'timeFrame': '12 months', 'description': 'Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.'}], 'secondaryOutcomes': [{'measure': 'Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.', 'timeFrame': 'at 12 months', 'description': 'Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.'}, {'measure': 'Visual Acuity After 12 Months of Wear', 'timeFrame': 'at 12 months', 'description': 'Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.'}, {'measure': 'Subjective Overall Comfort After 12 Months of Daily Wear', 'timeFrame': 'at 12 months', 'description': 'subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort'}, {'measure': 'Subjective Overall Vision After 12 Months of Daily Wear', 'timeFrame': 'at 12 months', 'description': 'subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Refractive Error', 'Myopia']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. They are of legal age (18 years) and capacity to volunteer.\n2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.\n3. They are willing and able to follow the protocol.\n4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.\n5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.\n6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).\n7. They have successfully worn contact lenses within six months of starting the study.\n\nExclusion Criteria:\n\n1. They have an ocular disorder which would normally contra-indicate contact lens wear.\n2. They have a systemic disorder which would normally contra-indicate contact lens wear.\n3. They are using any topical medication such as eye drops or ointment.\n4. They are aphakic.\n5. They have had corneal refractive surgery.\n6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.\n7. They are pregnant or lactating.\n8. 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.\n9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).\n10. They have diabetes.\n11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.'}, 'identificationModule': {'nctId': 'NCT00708032', 'briefTitle': 'Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.', 'orgStudyIdInfo': {'id': 'CR-0806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'spectacles', 'description': 'habitual spectacles worn daily for 12 months', 'interventionNames': ['Device: spectacles']}, {'type': 'EXPERIMENTAL', 'label': 'narafilcon A soft contact lenses', 'description': 'narafilcon A soft contact lenses worn as daily disposable for 12 months', 'interventionNames': ['Device: narafilcon A soft contact lenses']}], 'interventions': [{'name': 'spectacles', 'type': 'DEVICE', 'description': 'habitual spectacles', 'armGroupLabels': ['spectacles']}, {'name': 'narafilcon A soft contact lenses', 'type': 'DEVICE', 'description': 'narafilcon A daily disposable contact lenses', 'armGroupLabels': ['narafilcon A soft contact lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M60 1QD', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Eurolens Research, The University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}