Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT01787760
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Controlling Myopia Progression With 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': 'xcheng6@its.jnj.com', 'phone': '1 904 443-1245', 'title': 'XU CHENG, PRINCIPAL CLINICAL SCIENTIST', 'organization': 'Vistakon, USA'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Spectacle Lenses', 'description': 'Control spectacle lenses worn daily.', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test Soft Contact Lens B', 'description': 'Lenses will be worn in a daily disposable modality.', 'otherNumAtRisk': 51, 'otherNumAffected': 7, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Test Soft Contact Lens C', 'description': 'Lenses will be worn in a daily disposable modality.', 'otherNumAtRisk': 50, 'otherNumAffected': 4, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Not Randomized', 'description': 'Subjects who met the all study eligible criteria but did not randomize to the study arm.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Slit-lamp finding', 'notes': 'Slit Lamp findings Grade 2 or less requiring treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Axial Length (Axial Elongation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Spectacle Lenses', 'description': 'Control spectacle lenses worn daily.'}, {'id': 'OG001', 'title': 'Test Soft Contact Lens B', 'description': 'Lenses will be worn in a daily disposable modality.'}, {'id': 'OG002', 'title': 'Test Soft Contact Lens C', 'description': 'Lenses will be worn in a daily disposable modality.'}], 'classes': [{'title': 'Change from baseline 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.158', 'spread': '0.0981', 'groupId': 'OG000'}, {'value': '0.144', 'spread': '0.0834', 'groupId': 'OG001'}, {'value': '0.121', 'spread': '0.0749', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.242', 'spread': '0.1448', 'groupId': 'OG000'}, {'value': '0.236', 'spread': '0.1267', 'groupId': 'OG001'}, {'value': '0.222', 'spread': '0.1288', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 18 months; N=92, N=54, N=72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.348', 'spread': '0.2129', 'groupId': 'OG000'}, {'value': '0.355', 'spread': '0.1837', 'groupId': 'OG001'}, {'value': '0.344', 'spread': '0.1676', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 24 months; N=92, N=54, N=72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.455', 'spread': '0.2520', 'groupId': 'OG000'}, {'value': '0.409', 'spread': '0.2247', 'groupId': 'OG001'}, {'value': '0.445', 'spread': '0.2444', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.565', 'spread': '0.2941', 'groupId': 'OG000'}, {'value': '0.512', 'spread': '0.2634', 'groupId': 'OG001'}, {'value': '0.511', 'spread': '0.2564', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 36 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.640', 'spread': '0.3199', 'groupId': 'OG000'}, {'value': '0.634', 'spread': '0.3249', 'groupId': 'OG001'}, {'value': '0.512', 'spread': '0.3072', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and every 6 months post-baseline up to 3 years', 'description': 'Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.', 'unitOfMeasure': 'millimeter (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Analysis was conducted on all randomized subjects who have at least one data point.'}, {'type': 'PRIMARY', 'title': 'Spherical Equivalent Refraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Spectacle Lenses', 'description': 'Control spectacle lenses worn daily.'}, {'id': 'OG001', 'title': 'Test Soft Contact Lens B', 'description': 'Lenses will be worn in a daily disposable modality.'}, {'id': 'OG002', 'title': 'Test Soft Contact Lens C', 'description': 'Lenses will be worn in a daily disposable modality.'}], 'classes': [{'title': 'Change from baseline 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.238', 'spread': '0.3443', 'groupId': 'OG000'}, {'value': '-0.327', 'spread': '0.3038', 'groupId': 'OG001'}, {'value': '-0.230', 'spread': '0.3436', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.417', 'spread': '0.4557', 'groupId': 'OG000'}, {'value': '-0.456', 'spread': '0.3733', 'groupId': 'OG001'}, {'value': '-0.429', 'spread': '0.4199', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 18 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.562', 'spread': '0.5841', 'groupId': 'OG000'}, {'value': '-0.692', 'spread': '0.3965', 'groupId': 'OG001'}, {'value': '-0.720', 'spread': '0.4988', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.776', 'spread': '0.6185', 'groupId': 'OG000'}, {'value': '-0.781', 'spread': '0.4447', 'groupId': 'OG001'}, {'value': '-0.861', 'spread': '0.5504', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 30 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.966', 'spread': '0.7592', 'groupId': 'OG000'}, {'value': '-1.000', 'spread': '0.5485', 'groupId': 'OG001'}, {'value': '-1.003', 'spread': '0.6829', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline 36 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.073', 'spread': '0.9922', 'groupId': 'OG000'}, {'value': '-1.266', 'spread': '0.3193', 'groupId': 'OG001'}, {'value': '-0.824', 'spread': '0.8244', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and every 6 months post-baseline up to 3 years', 'description': 'Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.', 'unitOfMeasure': 'diopter (D)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Analysis was conducted on all randomized subjects who have at least one data point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Soft Contact Lens B', 'description': 'Lenses will be worn in a daily disposable modality'}, {'id': 'FG001', 'title': 'Test Soft Contact Lens C', 'description': 'Lenses will be worn in a daily disposable modality'}, {'id': 'FG002', 'title': 'Spectacle Lenses', 'description': 'Control spectacle lenses worn daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Anisometropia > -1.00D in spherical equi', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Decompensated on left exotropia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Dryness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lens discomfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lens handling difficulty', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Stroke', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory lens fitting performance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory physiological response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory visual response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Near vision blur', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of those 221 screened subjects, 56 were ineligible to participate in the study and 13 were eligible but not randomized to the study lens groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Soft Contact Lens B', 'description': 'Lenses will be worn in a daily disposable modality'}, {'id': 'BG001', 'title': 'Test Soft Contact Lens C', 'description': 'Lenses will be worn in a daily disposable modality'}, {'id': 'BG002', 'title': 'Spectacle Lenses', 'description': 'Control spectacle lenses worn daily.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '9.6', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '9.5', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '9.5', 'spread': '1.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'title': 'Hong Kong', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline summary was conducted on all randomized subjects.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2010-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2013-02-06', 'resultsFirstSubmitDate': '2015-07-01', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-01', 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial Length (Axial Elongation)', 'timeFrame': 'Baseline and every 6 months post-baseline up to 3 years', 'description': 'Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.'}, {'measure': 'Spherical Equivalent Refraction', 'timeFrame': 'Baseline and every 6 months post-baseline up to 3 years', 'description': 'Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject must be between 8 and 12 years of age and of Asia origin.\n2. The subject's best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)\n3. Astigmatism must be less than or equal to 1.00D\n4. Less than 1.00D difference in spherical equivalent between the two eyes\n5. The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes\n6. The subject must have at least 8D of accommodation.\n7. The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form\n8. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol\n\nExclusion Criteria:\n\n1. Ocular or systemic allergies or diseases that may interfere with contact lens wear\n2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear.\n3. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.\n4. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.\n5. Any ocular infection.\n6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n7. Any infectious disease (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).\n8. Diabetes.\n9. Anismetropia.\n10. Astigmatism of greater than 1.00D in either eye.\n11. Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.\n12. Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye\n13. Strabismus in either eye\n14. Pupil or lid abnormality or infection in either eye\n15. Central corneal scar and aphakia in either eye\n16. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear\n17. History of participation in clinical trials aimed to control myopia progression\n18. Surgically altered eyes, ocular infection of any type, ocular inflammation\n19. Subject has anterior chamber angle grade 2 or narrower"}, 'identificationModule': {'nctId': 'NCT01787760', 'briefTitle': 'Controlling Myopia Progression With Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Controlling Myopia Progression With Soft Contact Lenses', 'orgStudyIdInfo': {'id': 'CR-1561AC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Soft Contact Lens B', 'description': 'Lenses will be worn in a daily disposable modality', 'interventionNames': ['Device: Test Soft Contact Lens B']}, {'type': 'EXPERIMENTAL', 'label': 'Test Soft Contact Lens C', 'description': 'Lenses will be worn in a daily disposable modality', 'interventionNames': ['Device: Test Soft Contact Lens C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spectacle Lenses', 'description': 'Control spectacle lenses worn daily.', 'interventionNames': ['Device: Active Comparator']}], 'interventions': [{'name': 'Test Soft Contact Lens B', 'type': 'DEVICE', 'description': 'Test lenses to be worn in daily wear modality', 'armGroupLabels': ['Test Soft Contact Lens B']}, {'name': 'Test Soft Contact Lens C', 'type': 'DEVICE', 'description': 'Test lenses to be worn in a daily wear modality', 'armGroupLabels': ['Test Soft Contact Lens C']}, {'name': 'Active Comparator', 'type': 'DEVICE', 'description': 'Control spectacle lenses to be worn in a daily wear modality', 'armGroupLabels': ['Spectacle Lenses']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hung Hom', 'state': 'Kowloon', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.30715, 'lon': 114.18532}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}