Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-30 @ 5:06 AM
Study NCT ID:
NCT01031004
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2009-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vistakon Investigational Lens Worn as a Single Use Daily Wear
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': {'phone': '904-443-1707', 'title': 'John Buch/Principal Research Optometrist', '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 B', 'description': 'single use, daily wear contact lens', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Corneal Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Corneal Edema at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 month of lens wear', 'description': 'Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Corneal Neovascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Corneal Neovascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Tarsal Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Tarsal Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Infiltrates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Slit Lamp Findings - Infiltrates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Subject Reported Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0466', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The hypothesis is that narafilcon B is not statistically different from etafilcon A.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 week of lens wear', 'description': 'Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Subject Reported Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1069', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The hypothesis is that narafilcon B is not statistically different from etafilcon A.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 month of lens wear', 'description': 'Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Visual Acuity (VA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4605', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The hypothesis is that narafilcon B is not statistically different from etafilcon A.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 week', 'description': 'Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Visual Acuity (VA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5774', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The hypothesis is that narafilcon B is not statistically different from etafilcon A.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'after 1 month', 'description': 'Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Average Wear Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '2.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6403', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The hypothesis is that narafilcon B will not be statistically different from etafilcon A.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'after 1 week of lens wear', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Average Wear Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7217', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The hypothesis is that narafilcon B is not statistically different from etafilcon A.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'after 1 month of lens wear', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes all participants that completed the study per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'FG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Narafilcon B', 'description': 'single use, daily wear contact lens'}, {'id': 'BG001', 'title': 'Etafilcon A', 'description': 'contact lens worn as single use, daily wear'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '8.19', 'groupId': 'BG000'}, {'value': '29.2', 'spread': '8.08', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '8.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2009-11-18', 'resultsFirstSubmitDate': '2011-02-22', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-02-22', 'studyFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slit Lamp Findings - Corneal Edema', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.'}, {'measure': 'Corneal Edema at Month 1', 'timeFrame': 'after 1 month of lens wear', 'description': 'Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.'}, {'measure': 'Slit Lamp Findings - Corneal Neovascularization', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Corneal Neovascularization', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Corneal Staining', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Corneal Staining', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Injection', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Injection', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Tarsal Abnormalities', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Tarsal Abnormalities', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Infiltrates', 'timeFrame': 'after 1 week of lens wear', 'description': 'Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.'}, {'measure': 'Slit Lamp Findings - Infiltrates', 'timeFrame': 'after 1 month of lens wear', 'description': 'Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.'}, {'measure': 'Subject Reported Symptoms', 'timeFrame': 'after 1 week of lens wear', 'description': 'Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.'}, {'measure': 'Subject Reported Symptoms', 'timeFrame': 'after 1 month of lens wear', 'description': 'Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.'}, {'measure': 'Visual Acuity (VA)', 'timeFrame': 'after 1 week', 'description': 'Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.'}, {'measure': 'Visual Acuity (VA)', 'timeFrame': 'after 1 month', 'description': 'Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.'}, {'measure': 'Average Wear Time', 'timeFrame': 'after 1 week of lens wear'}, {'measure': 'Average Wear Time', 'timeFrame': 'after 1 month of lens wear'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eyes must be best-corrected to a visual acuity of 20/30 or better in each eye\n* must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study\n* distance spherical contact lens prescription must be within the range available for the study\n\nExclusion Criteria:\n\n* systemic diseases which may interfere with contact lens wear\n* ocular infection or clinically significant ocular disease\n* any previous intraocular surgery\n* grade 2 or greater slit lamp findings\n* currently pregnant or lactating\n* more than 1.00D of refractive astigmatism in either eye'}, 'identificationModule': {'nctId': 'NCT01031004', 'briefTitle': 'Vistakon Investigational Lens Worn as a Single Use Daily Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-1655'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'narafilcon B', 'description': 'contact lens', 'interventionNames': ['Device: narafilcon B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'etafilcon A', 'description': 'contact lens', 'interventionNames': ['Device: etafilcon A']}], 'interventions': [{'name': 'narafilcon B', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['narafilcon B']}, {'name': 'etafilcon A', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['etafilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23455', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '82070', 'city': 'Laramie', 'state': 'Wyoming', 'country': 'United States', 'geoPoint': {'lat': 41.31137, 'lon': -105.5911}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}