Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT03466060
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MBishop4@its.jnj.com', 'phone': '904-443-1396', 'title': 'Meredith Bishop, OD, MS, FAAO- Senior Principal Research Optometrist', 'organization': 'Johnson & Johnson Vision Care Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.'}}, 'adverseEventsModule': {'timeFrame': 'Throughout the entire duration of the study. Approximately 5-weeks per subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Etafilcon A - Revitalens', 'description': 'Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Etafilcon A - Clear Care', 'description': 'Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Etafilcon A- Optifree', 'description': 'Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the OPti-Free solution in one duringeither period 1 or period 2 during the study.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Senofilcon A - Revitalens', 'description': 'Subjects that wore the senfilcon A lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Senofilcon A - ClearCare', 'description': 'Subjects that wore the senofilcon A lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Senofilcon A - Opti-Free', 'description': 'Subjects that wore the senofilcon A lens throughout the entire duration of the study and the Opti-Free solution in one duringeither period 1 or period 2 during the study.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Senofilcon C- Revitalens', 'description': 'Subjects that wore the senofilcon C lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Senofilcon C - ClearCare', 'description': 'Subjects that wore the senofilcon C lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Senofilcon C - OptiFree', 'description': 'Subjects that wore the senofilcon C lens throughout the entire duration of the study and the Opti-Free solution in one duringeither period 1 or period 2 during the study.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Revita- Lens', 'description': 'All subject eyes that wore contact lenses pre-soaked in Revita-lens solution up to 2 hours regardless of the lens type.'}, {'id': 'OG001', 'title': 'Clear Care', 'description': 'All subject eyes that wore contact lenses pre-soaked in Clear Care solution up to 2 hours regardless of the lens type.'}, {'id': 'OG002', 'title': 'Opti-Free', 'description': 'All subjects eyes that wore contact lenses pre-soaked in Opit-Free solution up to 2 hours regardless of the lens type.'}], 'classes': [{'title': '1-Minute Follow-up', 'categories': [{'measurements': [{'value': '92.4', 'spread': '11.74', 'groupId': 'OG000'}, {'value': '92.4', 'spread': '10.52', 'groupId': 'OG001'}, {'value': '92.0', 'spread': '10.58', 'groupId': 'OG002'}]}]}, {'title': '5-Minute Follow-up', 'categories': [{'measurements': [{'value': '63.0', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '93.4', 'spread': '8.90', 'groupId': 'OG001'}, {'value': '92.3', 'spread': '9.81', 'groupId': 'OG002'}]}]}, {'title': '45 Minute Follow-up', 'categories': [{'measurements': [{'value': '93.5', 'spread': '9.48', 'groupId': 'OG000'}, {'value': '93.7', 'spread': '8.44', 'groupId': 'OG001'}, {'value': '93.5', 'spread': '7.96', 'groupId': 'OG002'}]}]}, {'title': '2-Hour Follow-up', 'categories': [{'measurements': [{'value': '94.7', 'spread': '7.06', 'groupId': 'OG000'}, {'value': '94.6', 'spread': '7.32', 'groupId': 'OG001'}, {'value': '94.3', 'spread': '7.39', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '2.3', 'pValueComment': '95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.23', 'estimateComment': 'Posterior mean difference was calculated as Test-Control.', 'groupDescription': '1-Minute Follow-up Analysis', 'statisticalMethod': 'bayesian multivariate hierarachical', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Posertior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '1.7', 'pValueComment': '95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.16', 'estimateComment': 'Posterior mean difference was calculated as Test-Control.', 'groupDescription': '5-minute Follow-up Analysis', 'statisticalMethod': 'Bayesian Multivariate Hierarchical Model', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '1.5', 'pValueComment': '95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.10', 'estimateComment': 'Posterior mean difference was calculated as Test-Control.', 'groupDescription': '45-Minute Follolw-up Analysis', 'statisticalMethod': 'Bayesian multivariate hierarchical model', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.01', 'estimateComment': 'Posterior mean difference was calculated as Test-Control.', 'groupDescription': '2-Hour Follow-up Analysis', 'statisticalMethod': 'Bayesian Multivariate Heirarchical Model', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '3.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.28', 'estimateComment': 'Posterior mean difference was calculated as Test-Control.', 'groupDescription': '1-Minute Follow-up Analysis', 'statisticalMethod': 'Bayesian Multivariate Heirarchical Model', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '3.6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.20', 'estimateComment': 'Posterior mean difference was calculated as Test-Control.', 'groupDescription': '5-Minute Follow-up Analysis', 'statisticalMethod': 'Bayesian Multivariate Heirarchical Model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': '95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.16', 'estimateComment': 'Posterior mean difference was calculated as Test-Control.', 'groupDescription': '45-Minute Follow-up Analysis', 'statisticalMethod': 'Bayesian Multivariate Hierarchical Model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '2.5', 'pValueComment': '95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.10', 'estimateComment': 'Posterior mean difference was calculated as Test-Control.', 'groupDescription': '2-Hour Follow-up Analysis', 'statisticalMethod': 'Bayesian Mutlivariate Hiearachical Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2-Hours Post Lens Fitting', 'description': 'Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All subjects who successfully completed all study visits without a major protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etafilcon A-Opti-Free/Clear Care', 'description': 'Subjects that were dispensed the etafilcon A lens throughout the entire study and received Opti-Free in one eye during first period and Clear in one eye during second period. During both periods Revitalens was received on the contralateral eye.'}, {'id': 'FG001', 'title': 'Etafilcon A-Clear Care/Opti-Free', 'description': 'Subjects that were dispensed the etafilcon A lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.'}, {'id': 'FG002', 'title': 'Senofilcon A-Opti-free/Clear Care', 'description': 'Subjects that were dispensed the senofilcon A lens throughout the entire study and received Opti-Free in one eye during first period and Clear Care in one eye during second period. During both periods Revitalens was received on the contralateral eye.'}, {'id': 'FG003', 'title': 'Senofilcon A-Clear Care/Opti-Free', 'description': 'Subjects that were dispensed the senofilcon A lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.'}, {'id': 'FG004', 'title': 'Senofilcon C-Opti-Free/Clear Care', 'description': 'Subjects that were dispensed the senofilcon C lens throughout the entire study and received Opti-Free in one eye during first period and Clear Care in one eye during second period. During both periods Revitalens was received on the contralateral eye.'}, {'id': 'FG005', 'title': 'Senofilcon C-Clear Care/Opti-Free', 'description': 'Subjects that were dispensed the senofilcon C lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Test Lens Damage', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Grade 2 Conjunctivitis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lens Handling Difficulties', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 130 subjects were enrolled into this study. Of those enrolled, 113 subjects were assigned and dispensed a study lens while, 15 subjects were screen failures and 2 subjects were assigned but not administered the Test article. Of those dispensed, 106 subjects completed the study while, 7 subjects were discontinued.', 'preAssignmentDetails': 'Of those that completed the study, 78 subjects completed without a major protocol deviation impacting a primary endpoint.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Etafilcon A', 'description': 'Subjects that wore the etafilcon A lens during the entire study.'}, {'id': 'BG001', 'title': 'Senofilcon A', 'description': 'Subjects that wore the senofilcon A lens during the entire study.'}, {'id': 'BG002', 'title': 'Senofilcon C', 'description': 'Subjects that wore the senofilcon C lens during the entire study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '9.41', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '7.82', 'groupId': 'BG001'}, {'value': '29.1', 'spread': '10.52', 'groupId': 'BG002'}, {'value': '28.3', 'spread': '9.25', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Island', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects dispensed a study lens.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-08', 'size': 6459648, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-19T10:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2018-02-26', 'resultsFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-01', 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Comfort', 'timeFrame': 'Up to 2-Hours Post Lens Fitting', 'description': 'Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)']}, 'descriptionModule': {'briefSummary': 'This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Potential subjects must satisfy all of the following criteria to be enrolled in the study:\n\n 1. Subjects must be 18-69 years of age (inclusive).\n 2. Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.\n 3. Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.\n 4. The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.\n 5. The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.\n 6. The subject must have normal eyes (i.e., no ocular medications or infections of any type).\n 7. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).\n 8. Subjects must read, understand, and sign the Statement of Informed Consent.\n 9. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.\n\n Exclusion Criteria:\n* Potential subjects who meet any of the following criteria will be excluded from participating in the study:\n\n 1. Currently pregnant or breast-feeding.\n 2. Diabetes\n 3. Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).\n 4. Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).\n 5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.\n 6. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).\n 7. Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.\n 8. Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.\n 9. Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.\n 10. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).\n 11. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.\n 12. History of any ocular or corneal surgery (eg, RK, PRK, LASIK).\n 13. Habitual contact lens wear modality as extended wear.\n 14. Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.\n 15. History of binocular vision abnormality or strabismus.\n 16. Habitual wearers of rigid gas permeable lens within the past 3 months.\n 17. Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report"}, 'identificationModule': {'nctId': 'NCT03466060', 'briefTitle': 'Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types', 'orgStudyIdInfo': {'id': 'CR-6012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'etafilcon A', 'description': 'Eligible subjects were randomized to the etafilcon A lens in both eyes throughout the entire duration of the study.', 'interventionNames': ['Device: Opti-Free : RevitaLens / Clear Care : RevitaLens', 'Device: Opti-Free : RevitaLens / RevitaLens : Clear Care', 'Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens', 'Device: Clear Care : RevitaLens / RevitaLens : Opti-Free', 'Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens', 'Device: RevitaLens : Clear Care / RevitaLens : Opti-Free', 'Device: RevitaLens : Opti-Free / Clear Care : RevitaLens', 'Device: RevitaLens : Opit-Free / RevitaLens : Clear Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'senofilcon A', 'description': 'Eligible subjects were randomized to the senofilcon A lens in both eyes throughout the entire duration of the study.', 'interventionNames': ['Device: Opti-Free : RevitaLens / Clear Care : RevitaLens', 'Device: Opti-Free : RevitaLens / RevitaLens : Clear Care', 'Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens', 'Device: Clear Care : RevitaLens / RevitaLens : Opti-Free', 'Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens', 'Device: RevitaLens : Clear Care / RevitaLens : Opti-Free', 'Device: RevitaLens : Opti-Free / Clear Care : RevitaLens', 'Device: RevitaLens : Opit-Free / RevitaLens : Clear Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'senofilcon C', 'description': 'Eligible subjects were randomized to the senofilcon C lens in both eyes throughout the entire duration of the study.', 'interventionNames': ['Device: Opti-Free : RevitaLens / Clear Care : RevitaLens', 'Device: Opti-Free : RevitaLens / RevitaLens : Clear Care', 'Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens', 'Device: Clear Care : RevitaLens / RevitaLens : Opti-Free', 'Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens', 'Device: RevitaLens : Clear Care / RevitaLens : Opti-Free', 'Device: RevitaLens : Opti-Free / Clear Care : RevitaLens', 'Device: RevitaLens : Opit-Free / RevitaLens : Clear Care']}], 'interventions': [{'name': 'Opti-Free : RevitaLens / Clear Care : RevitaLens', 'type': 'DEVICE', 'otherNames': ['Right eye : left eye / right eye : left eye'], 'description': "Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.", 'armGroupLabels': ['etafilcon A', 'senofilcon A', 'senofilcon C']}, {'name': 'Opti-Free : RevitaLens / RevitaLens : Clear Care', 'type': 'DEVICE', 'otherNames': ['Right eye : left eye / right eye : left eye'], 'description': "Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.", 'armGroupLabels': ['etafilcon A', 'senofilcon A', 'senofilcon C']}, {'name': 'Clear Care : RevitaLens/ Opti-Free : RevitaLens', 'type': 'DEVICE', 'otherNames': ['Right eye : left eye / right eye : left eye'], 'description': "Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.", 'armGroupLabels': ['etafilcon A', 'senofilcon A', 'senofilcon C']}, {'name': 'Clear Care : RevitaLens / RevitaLens : Opti-Free', 'type': 'DEVICE', 'otherNames': ['Right eye : left eye / right eye : left eye'], 'description': "Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.", 'armGroupLabels': ['etafilcon A', 'senofilcon A', 'senofilcon C']}, {'name': 'RevitaLens : Clear Care/ Opti-Free : RevitaLens', 'type': 'DEVICE', 'otherNames': ['Right eye : left eye / right eye : left eye'], 'description': "Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.", 'armGroupLabels': ['etafilcon A', 'senofilcon A', 'senofilcon C']}, {'name': 'RevitaLens : Clear Care / RevitaLens : Opti-Free', 'type': 'DEVICE', 'otherNames': ['Right eye : left eye / right eye : left eye'], 'description': "Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.", 'armGroupLabels': ['etafilcon A', 'senofilcon A', 'senofilcon C']}, {'name': 'RevitaLens : Opti-Free / Clear Care : RevitaLens', 'type': 'DEVICE', 'otherNames': ['Right eye : left eye / right eye : left eye'], 'description': "Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.", 'armGroupLabels': ['etafilcon A', 'senofilcon A', 'senofilcon C']}, {'name': 'RevitaLens : Opit-Free / RevitaLens : Clear Care', 'type': 'DEVICE', 'otherNames': ['Right eye : left eye / right eye : left eye'], 'description': "Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.", 'armGroupLabels': ['etafilcon A', 'senofilcon A', 'senofilcon C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92807', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Southern California College of Optometry', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94720', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Berkeley School of Optometry', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Vue Optical Boutique', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77240', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston College of Optometry', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}