Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT03471832
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Stenfilcon A 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': 'javega@coopervision.com', 'phone': '9256213761', 'title': 'Jose A.Vega, O.D., MSc., FAAO', 'organization': 'CooperVision'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From insertion over three hours of lens wear', 'eventGroups': [{'id': 'EG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Tight', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly tight', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Loose', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Loose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes', 'description': 'Movement of lens after blink: (Categories = Tight, Slightly 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'0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly tight', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Loose', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Loose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3hrs', 'description': 'Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)', 'unitOfMeasure': 'Number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Horizontal Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Temporal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly temporal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Center', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Slightly nasal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nasal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes', 'description': 'Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)', 'unitOfMeasure': 'Number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Horizontal Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and 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'paramType': 'NUMBER', 'timeFrame': '3hrs', 'description': 'Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)', 'unitOfMeasure': 'number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Vertical Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Superior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly superior', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Center', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inferior', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Inferior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes', 'description': 'Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)', 'unitOfMeasure': 'Number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Vertical Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Superior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly superior', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Center', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inferior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Inferior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3hrs', 'description': 'Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)', 'unitOfMeasure': 'Count of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes', 'description': 'Does lens cover the cornea: (Yes, No)', 'unitOfMeasure': 'number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3hrs', 'description': 'Does lens cover the cornea: (Yes, No)', 'unitOfMeasure': 'number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Lens Lag', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Move along with cornea', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Delay', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Delay', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes', 'description': 'Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)', 'unitOfMeasure': 'number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Lens Lag', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized 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'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Overall Fitting Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes', 'description': 'Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)', 'unitOfMeasure': 'number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Overall Fitting Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3hrs', 'description': 'Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)', 'unitOfMeasure': 'number of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Investigator Fit Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study - Investigator Fitting Preference', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens narafilcon A lens: contact lens'}], 'classes': [{'title': 'Prefer stenfilcon A strongly', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Prefer stenfilcon A slightly', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Either', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Prefer narafilcon A slightly', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Prefer narafilcon A strongly', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 minutes', 'description': 'Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Investigator Fit Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study - Investigator Fitting Preference', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens narafilcon A lens: contact lens'}], 'classes': [{'title': 'Prefer stenfilcon A strongly', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Prefer stenfilcon A slightly', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Either', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Prefer narafilcon A slightly', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Prefer narafilcon A strongly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3hrs', 'description': 'Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, 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[{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))', 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{'value': '9.0', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'description': 'Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Stinging/Burning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'OG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hours', 'description': 'Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Edge/Lens Awareness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized 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'Prefer narafilcon A', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Lens preference (stenfilcon A, Either, Neither, narafilcon A)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.'}, {'type': 'SECONDARY', 'title': 'Subjective Lens Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens Preference - After Insertion', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}], 'classes': [{'title': 'Prefer stenfilcon A', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Either', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Neither', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Prefer narafilcon A', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 minutes', 'description': 'Lens preference (stenfilcon A, Either, Neither, narafilcon A)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.'}, {'type': 'SECONDARY', 'title': 'Subjective Lens Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens Preference - After Insertion', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}], 'classes': [{'title': 'Prefer stenfilcon A', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Either', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Neither', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Prefer narafilcon A', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 hours', 'description': 'Lens preference (stenfilcon A, Either, Neither, narafilcon A)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stenfilcon A Lens', 'description': 'Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study.\n\nstenfilcon A lens: contact lens'}, {'id': 'FG001', 'title': 'Narafilcon A Lens', 'description': 'Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study.\n\nnarafilcon A lens: contact lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '40', 'numSubjects': '40'}, {'groupId': 'FG001', 'numUnits': '40', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '40', 'numSubjects': '40'}, {'groupId': 'FG001', 'numUnits': '40', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Total Participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-26', 'size': 724230, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-23T09:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Each subject will be masked as to which lens is worn on each eye.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'dispFirstSubmitDate': '2019-07-30', 'completionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2018-03-14', 'dispFirstSubmitQcDate': '2019-07-30', 'resultsFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2018-03-19', 'dispFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-14', 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Movement', 'timeFrame': '5 minutes', 'description': 'Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)'}, {'measure': 'Lens Movement', 'timeFrame': '3hrs', 'description': 'Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)'}, {'measure': 'Horizontal Lens Centration', 'timeFrame': '5 minutes', 'description': 'Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)'}, {'measure': 'Horizontal Lens Centration', 'timeFrame': '3hrs', 'description': 'Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)'}, {'measure': 'Vertical Lens Centration', 'timeFrame': '5 minutes', 'description': 'Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)'}, {'measure': 'Vertical Lens Centration', 'timeFrame': '3hrs', 'description': 'Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)'}, {'measure': 'Corneal Coverage', 'timeFrame': '5 minutes', 'description': 'Does lens cover the cornea: (Yes, No)'}, {'measure': 'Corneal Coverage', 'timeFrame': '3hrs', 'description': 'Does lens cover the cornea: (Yes, No)'}, {'measure': 'Lens Lag', 'timeFrame': '5 minutes', 'description': 'Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)'}, {'measure': 'Lens Lag', 'timeFrame': '3hrs', 'description': 'Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)'}, {'measure': 'Overall Fitting Performance', 'timeFrame': '5 minutes', 'description': 'Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)'}, {'measure': 'Overall Fitting Performance', 'timeFrame': '3hrs', 'description': 'Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)'}, {'measure': 'Investigator Fit Preference', 'timeFrame': '5 minutes', 'description': 'Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)'}, {'measure': 'Investigator Fit Preference', 'timeFrame': '3hrs', 'description': 'Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)'}], 'secondaryOutcomes': [{'measure': 'Comfort', 'timeFrame': 'Baseline', 'description': 'Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))'}, {'measure': 'Comfort', 'timeFrame': '5 Minutes', 'description': 'Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))'}, {'measure': 'Comfort', 'timeFrame': '3 hours', 'description': 'Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))'}, {'measure': 'Dryness', 'timeFrame': 'Baseline', 'description': 'Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))'}, {'measure': 'Dryness', 'timeFrame': '5 minutes', 'description': 'Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))'}, {'measure': 'Dryness', 'timeFrame': '3 hours', 'description': 'Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))'}, {'measure': 'Stinging/Burning', 'timeFrame': 'Baseline', 'description': 'Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))'}, {'measure': 'Stinging/Burning', 'timeFrame': '5 minutes', 'description': 'Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))'}, {'measure': 'Stinging/Burning', 'timeFrame': '3 hours', 'description': 'Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))'}, {'measure': 'Edge/Lens Awareness', 'timeFrame': 'Baseline', 'description': 'Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))'}, {'measure': 'Edge/Lens Awareness', 'timeFrame': '5 minutes', 'description': 'Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))'}, {'measure': 'Edge/Lens Awareness', 'timeFrame': '3 hours', 'description': 'Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))'}, {'measure': 'Subjective Lens Preference', 'timeFrame': 'Baseline', 'description': 'Lens preference (stenfilcon A, Either, Neither, narafilcon A)'}, {'measure': 'Subjective Lens Preference', 'timeFrame': '5 minutes', 'description': 'Lens preference (stenfilcon A, Either, Neither, narafilcon A)'}, {'measure': 'Subjective Lens Preference', 'timeFrame': '3 hours', 'description': 'Lens preference (stenfilcon A, Either, Neither, narafilcon A)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).', 'detailedDescription': 'This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA person is eligible for inclusion in the study if he/she:\n\n* Is Japanese\n* Has had a self-reported oculo-visual examination in the last two years.\n* Is at least 18 years of age and has full legal capacity to volunteer.\n* Has read and understood the informed consent letter.\n* Is willing and able to follow instructions and maintain the appointment schedule.\n* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.\n* Currently wears soft contact lenses.\n* Has clear corneas and no active ocular disease.\n\nExclusion Criteria:\n\nA person will be excluded from the study if he/she:\n\n* Has never worn contact lenses before.\n* Has any systemic disease affecting ocular health.\n* Is using any systemic or topical medications that will affect ocular health.\n* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.\n* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.\n* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.\n* Is aphakic.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT03471832', 'briefTitle': 'Clinical Evaluation of Stenfilcon A Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Evaluation of CooperVision MyDay Lenses', 'orgStudyIdInfo': {'id': 'JP-MKTG-201709_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stenfilcon A lens', 'description': 'MyDay contact lens', 'interventionNames': ['Device: stenfilcon A lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'narafilcon A lens', 'description': '1-Day Acuvue TruEye', 'interventionNames': ['Device: narafilcon A lens']}], 'interventions': [{'name': 'stenfilcon A lens', 'type': 'DEVICE', 'otherNames': ['MyDay, test'], 'description': 'contact lens', 'armGroupLabels': ['stenfilcon A lens']}, {'name': 'narafilcon A lens', 'type': 'DEVICE', 'otherNames': ['1-day Acuvue TruEye, control'], 'description': 'contact lens', 'armGroupLabels': ['narafilcon A lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '960-8034', 'city': 'Fukushima', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Shioya Eye Clinic', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '610-0121', 'city': 'Terada', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kodama Eye Clinic', 'geoPoint': {'lat': 34.85, 'lon': 135.76667}}, {'zip': '15-0043', 'city': 'Shibuya City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Itoi Eye Clinic', 'geoPoint': {'lat': 35.6589, 'lon': 139.70665}}, {'zip': '751-0872', 'city': 'Shimonoseki', 'state': 'Yamaguchi', 'country': 'Japan', 'facility': 'Ueda Eye Clinic', 'geoPoint': {'lat': 33.95548, 'lon': 130.93713}}], 'overallOfficials': [{'name': 'Yuji Kodama, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kodama Eye Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}