Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT02719366
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mnguyen@coopervision.com', 'phone': '925-730-6716', 'title': 'Myhanh Nguyen', 'organization': 'CooperVision, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to 4 days on each pair of lenses.', 'eventGroups': [{'id': 'EG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'title': 'Distance', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Intermediate', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Near', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'title': 'Distance', 'categories': [{'measurements': [{'value': '65', 'spread': '27', 'groupId': 'OG000'}, {'value': '64', 'spread': '22', 'groupId': 'OG001'}]}]}, {'title': 'Intermediate', 'categories': [{'measurements': [{'value': '77', 'spread': '16', 'groupId': 'OG000'}, {'value': '78', 'spread': '18', 'groupId': 'OG001'}]}]}, {'title': 'Near', 'categories': [{'measurements': [{'value': '76', 'spread': '18', 'groupId': 'OG000'}, {'value': '65', 'spread': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'spread': '8', 'groupId': 'OG000'}, {'value': '88', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'spread': '23', 'groupId': 'OG000'}, {'value': '80', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'spread': '21', 'groupId': 'OG000'}, {'value': '87', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'spread': '17', 'groupId': 'OG000'}, {'value': '81', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Preference for Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens or control lens bilaterally for four days in this cross-over study.'}], 'classes': [{'title': 'Test Lens', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Control Lens', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 days', 'description': 'Subjective preference for comfort for test and control contact lenses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '22', 'groupId': 'OG000'}, {'value': '75', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Subjective satisfaction for test and control lens. Scale 0-100, 0=extremely dissatisfied, 100=very satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Preference for Near Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens or control lens bilaterally for four days in this cross-over study.'}], 'classes': [{'title': 'Test Lens', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Control Lens', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 days', 'description': 'Subjective preference for Near Vision for test and control contact lenses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Preference for Intermediate Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens or control lens bilaterally for four days in this cross-over study.'}], 'classes': [{'title': 'Test Lens', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Control Lens', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 days', 'description': 'Subjective preference for intermediate vision for test and control contact lenses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Preference for Distance Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens or control lens bilaterally for four days in this cross-over study.'}], 'classes': [{'title': 'Test Lens', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Control Lens', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 days', 'description': 'Subjective preference for distance vision for test and control contact lenses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Overall Vision Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens or control lens bilaterally for four days in this cross-over study.'}], 'classes': [{'title': 'Test Lens', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Control Lens', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 days', 'description': 'Subjective overall vision preference for test and control contact lenses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Wearing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '3', 'groupId': 'OG000'}, {'value': '11', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Average daily wearing time for test and control lens is assessed in hours.', 'unitOfMeasure': 'Hours/Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 scale in 0.25 steps 0- very poor fit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Handling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'spread': '13', 'groupId': 'OG000'}, {'value': '88', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 Days', 'description': 'Subjective ratings for handling (ease of insertion and removal) was assessed on a Scale of 0-100 (0=very difficult to handle, 100=easy to handle).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bulbar Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Limbal Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Extended Range Test Lens', 'description': 'Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses'}, {'id': 'OG001', 'title': 'Comfilcon A Control Lens', 'description': 'Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study.\n\ncomfilcon A control lens: contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Lens Then Control Lens', 'description': 'Subjects will be randomized to wear the test contact lenses first then control contact lenses bilaterally for four days in the cross-over study.\n\ncomfilcon A Extended Range test lens: contact lenses\n\ncomfilcon A control lens: contact lenses'}, {'id': 'FG001', 'title': 'Control Lens Then Test Lens', 'description': 'Subjects will be randomized to wear the control contact lenses first then test contact lenses bilaterally for four days in the cross-over study.\n\ncomfilcon A control lens: contact lenses\n\ncomfilcon A Extended Range test lens: contact lenses'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Subjects will be randomized to wear the test contact lenses or control contact lenses bilaterally first for four days then cross-over to alternate study lenses.\n\ncomfilcon A Extended Range test lens: contact lenses\n\ncomfilcon A control lens: contact lenses'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', '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': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2016-03-21', 'resultsFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-02', 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '4 days', 'description': 'Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR.'}, {'measure': 'Visual Performance', 'timeFrame': '4 days', 'description': 'Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).'}], 'secondaryOutcomes': [{'measure': 'Comfort', 'timeFrame': 'Baseline', 'description': 'Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).'}, {'measure': 'Comfort', 'timeFrame': '4 days', 'description': 'Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).'}, {'measure': 'Dryness', 'timeFrame': 'Baseline', 'description': 'Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).'}, {'measure': 'Dryness', 'timeFrame': '4 days', 'description': 'Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).'}, {'measure': 'Subjective Preference for Comfort', 'timeFrame': '4 days', 'description': 'Subjective preference for comfort for test and control contact lenses.'}, {'measure': 'Subjective Satisfaction', 'timeFrame': '4 days', 'description': 'Subjective satisfaction for test and control lens. Scale 0-100, 0=extremely dissatisfied, 100=very satisfied)'}, {'measure': 'Subjective Preference for Near Vision', 'timeFrame': '4 days', 'description': 'Subjective preference for Near Vision for test and control contact lenses.'}, {'measure': 'Subjective Preference for Intermediate Vision', 'timeFrame': '4 days', 'description': 'Subjective preference for intermediate vision for test and control contact lenses.'}, {'measure': 'Subjective Preference for Distance Vision', 'timeFrame': '4 days', 'description': 'Subjective preference for distance vision for test and control contact lenses.'}, {'measure': 'Subjective Overall Vision Preference', 'timeFrame': '4 days', 'description': 'Subjective overall vision preference for test and control contact lenses.'}, {'measure': 'Average Daily Wearing Time', 'timeFrame': '4 days', 'description': 'Average daily wearing time for test and control lens is assessed in hours.'}, {'measure': 'Lens Fit', 'timeFrame': '4 days', 'description': 'Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 scale in 0.25 steps 0- very poor fit.'}, {'measure': 'Lens Handling', 'timeFrame': '4 Days', 'description': 'Subjective ratings for handling (ease of insertion and removal) was assessed on a Scale of 0-100 (0=very difficult to handle, 100=easy to handle).'}, {'measure': 'Bulbar Hyperemia', 'timeFrame': '4 days', 'description': 'Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia'}, {'measure': 'Limbal Hyperemia', 'timeFrame': '4 days', 'description': 'Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.', 'detailedDescription': 'This study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA person is eligible for inclusion in the study if he/she:\n\n* Has had a self-reported oculo-visual examination in the last two years\n* Is 50 years of age or greater and has full legal capacity to volunteer\n* Is able to read and understand the informed consent\n* Is willing and able to follow instructions and maintain the appointment schedule\n* Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)\n* Near Add Power requirement of +2.25D or greater\n* Has spectacle cylinder 0.75 D in both eyes\n* Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)\n* Has monocular best-corrected distance visual acuity of 20/30 or better in each eye\n* Has clear corneas and no active ocular disease\n* Has not worn gas permeable contact lenses for 1 month prior to the study\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 abnormality that would affect the wearing of contact lenses\n* Is aphakic (i.e. missing their natural lens inside their eye)\n* Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D\n* Has undergone corneal refractive surgery\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT02719366', 'briefTitle': 'A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses', 'orgStudyIdInfo': {'id': 'CV-16-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'comfilcon A Extended Range test lens', 'description': 'Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.', 'interventionNames': ['Device: comfilcon A Extended Range test lens', 'Device: comfilcon A control lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comfilcon A control lens', 'description': 'Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.', 'interventionNames': ['Device: comfilcon A Extended Range test lens', 'Device: comfilcon A control lens']}], 'interventions': [{'name': 'comfilcon A Extended Range test lens', 'type': 'DEVICE', 'description': 'contact lenses', 'armGroupLabels': ['comfilcon A Extended Range test lens', 'comfilcon A control lens']}, {'name': 'comfilcon A control lens', 'type': 'DEVICE', 'description': 'contact lenses', 'armGroupLabels': ['comfilcon A Extended Range test lens', 'comfilcon A control lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Center, University of California, Berkeley', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'Meng C Lin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CRC, UC Berkeley'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}