Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04050618
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2019-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in 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': {'email': 'javega@coopervision.com', 'phone': '925-621-3761', 'title': 'Jose A. Vega, O.D., MSc, FAAO', 'organization': 'CooperVision, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to 4 weeks for ocufilcon D and fanfilcon A - Group A, from dispense up to 2 weeks for etafilcon A and fanfilcon A - Group B. A total of 8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 2, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Overall Comfort Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '1.72', 'groupId': 'OG002'}, {'value': '8.3', 'spread': '1.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two weeks', 'description': "Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Overall Comfort Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Four weeks', 'description': "Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Wearing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '14.01', 'spread': '1.689', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '1.674', 'groupId': 'OG001'}, {'value': '13.84', 'spread': '1.756', 'groupId': 'OG002'}, {'value': '13.80', 'spread': '1.757', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two weeks', 'description': 'Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Wearing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '14.21', 'spread': '1.501', 'groupId': 'OG000'}, {'value': '14.42', 'spread': '1.504', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Four weeks', 'description': 'Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Comfortable Wearing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '11.60', 'spread': '3.743', 'groupId': 'OG000'}, {'value': '12.45', 'spread': '3.669', 'groupId': 'OG001'}, {'value': '12.18', 'spread': '3.210', 'groupId': 'OG002'}, {'value': '11.67', 'spread': '3.330', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two weeks', 'description': 'Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Comfortable Wearing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '11.37', 'spread': '3.869', 'groupId': 'OG000'}, {'value': '12.40', 'spread': '3.379', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Four weeks', 'description': 'Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Optimal', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}]}, {'title': 'Slight', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Substantial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (after 15 minutes)', 'description': 'Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\\>0.5mm)).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Optimal', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}]}, {'title': 'Slight', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Substantial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Two weeks', 'description': 'Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\\>0.5mm)).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Optimal', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Slight', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Substantial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Four weeks', 'description': 'Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\\>0.5mm)).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Two weeks', 'description': 'Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Four weeks', 'description': 'Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Post-Blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Insufficient', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Optimal', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Post-Blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Insufficient', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Optimal', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Two weeks', 'description': 'Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Post-Blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for 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'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '48.4', 'spread': '4.55', 'groupId': 'OG001'}, {'value': '50.6', 'spread': '5.88', 'groupId': 'OG002'}, {'value': '48.0', 'spread': '7.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two weeks', 'description': 'Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)', 'unitOfMeasure': 'percentage of eyes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Lens Tightness - Push-up Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '112', 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Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Should not be worn', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Borderline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'OK', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Perfect', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Should not be worn', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Borderline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'OK', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Perfect', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Two weeks', 'description': 'Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not 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'Borderline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'OK', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Perfect', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Four weeks', 'description': 'Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Rating of Lens Surface Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear 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'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.74', 'spread': '0.490', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '0.512', 'groupId': 'OG001'}, {'value': '3.73', 'spread': '0.611', 'groupId': 'OG002'}, {'value': '3.80', 'spread': '0.437', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two weeks', 'description': 'Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Rating of Lens Surface Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '0.736', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '0.365', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Four weeks', 'description': 'Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Presence of Film Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Grade 0', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Two weeks', 'description': 'Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Presence of Film Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Grade 0', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Four weeks', 'description': 'Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Number of White Spot Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.567', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.211', 'groupId': 'OG002'}, {'value': '0.22', 'spread': '1.145', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two weeks', 'description': 'Number of white spot deposits assessed using slit lamp with white light, low medium magnification', 'unitOfMeasure': 'number of white spots', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Number of White Spot Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.988', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.940', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Four weeks', 'description': 'Number of white spot deposits assessed using slit lamp with white light, low medium magnification', 'unitOfMeasure': 'number of white spots', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Primary Gaze Lag', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Insufficient', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Optimal', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Primary Gaze Lag', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}, {'id': 'OG002', 'title': 'Etafilcon A - Group B', 'description': 'Subjects were randomized to wear etafilcon A control lens for two weeks.\n\nEtafilcon A - hydrogel contact lens'}, {'id': 'OG003', 'title': 'Fanfilcon A - Group B', 'description': 'Subjects were randomized to wear fanfilcon A test lens for two weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Insufficient', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Optimal', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Two weeks', 'description': 'Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Primary Gaze Lag', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nFanfilcon A - SiHy contact lens'}], 'classes': [{'title': 'Insufficient', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Optimal', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Four weeks', 'description': 'Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.55', 'spread': '1.607', 'groupId': 'OG000'}, {'value': '9.22', 'spread': '1.146', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 - 8:00am', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.58', 'spread': '1.601', 'groupId': 'OG000'}, {'value': '9.27', 'spread': '1.180', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 - 12:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.85', 'spread': '1.384', 'groupId': 'OG000'}, {'value': '8.71', 'spread': '1.458', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 - 4:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.11', 'spread': '1.912', 'groupId': 'OG000'}, {'value': '8.57', 'spread': '1.377', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 - 8:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.13', 'spread': '1.727', 'groupId': 'OG000'}, {'value': '8.84', 'spread': '1.328', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 - 8:00am', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.48', 'spread': '1.750', 'groupId': 'OG000'}, {'value': '8.98', 'spread': '1.336', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 - 12:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.39', 'spread': '1.869', 'groupId': 'OG000'}, {'value': '8.84', 'spread': '1.261', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 - 4:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.22', 'spread': '1.920', 'groupId': 'OG000'}, {'value': '8.48', 'spread': '1.722', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 - 8:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.28', 'spread': '1.896', 'groupId': 'OG000'}, {'value': '8.85', 'spread': '1.348', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 - 8:00am', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.68', 'spread': '1.721', 'groupId': 'OG000'}, {'value': '8.73', 'spread': '1.387', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 - 12:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.34', 'spread': '1.710', 'groupId': 'OG000'}, {'value': '8.56', 'spread': '1.459', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 - 4:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.22', 'spread': '2.023', 'groupId': 'OG000'}, {'value': '8.39', 'spread': '1.382', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 - 8:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.35', 'spread': '1.861', 'groupId': 'OG000'}, {'value': '8.58', 'spread': '1.277', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 26 - 8:00am', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.22', 'spread': '1.741', 'groupId': 'OG000'}, {'value': '8.80', 'spread': '1.392', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 26 - 12:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.04', 'spread': '1.876', 'groupId': 'OG000'}, {'value': '8.62', 'spread': '1.609', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 26 - 4:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}, {'type': 'SECONDARY', 'title': 'Comfort Throughout the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocufilcon D - Group A', 'description': 'Subjects were randomized to wear ocufilcon D control lens for four weeks.\n\nOcufilcon D - hydrogel contact lens'}, {'id': 'OG001', 'title': 'Fanfilcon A - Group A', 'description': 'Subjects were randomized to wear fanfilcon A test lens for four weeks.\n\nfanfilcon A - SiHy contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '7.79', 'spread': '2.127', 'groupId': 'OG000'}, {'value': '8.29', 'spread': '1.774', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 26 - 8:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on the number of text responses received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ocufilcon D Control Lens, Then Fanfilcon A Test Lens', 'description': 'Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.\n\nocufilcon D control lens: hydrogel contact lens\n\nfanfilcon A test lens: Silicone hydrogel contact lens'}, {'id': 'FG001', 'title': 'Etafilcon A Controls, Then Fanfilcon A Test Lens', 'description': 'Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.\n\netafilcon A control lens: hydrogel contact lens\n\nfanfilcon A test lens: Silicone hydrogel contact lens'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ocufilcon D Control Lens, Then Fanfilcon A Test Lens', 'description': 'Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.\n\nocufilcon D control lens: hydrogel contact lens\n\nfanfilcon A test lens: Silicone hydrogel contact lens'}, {'id': 'BG001', 'title': 'Etafilcon A Controls, Then Fanfilcon A Test Lens', 'description': 'Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.\n\netafilcon A control lens: hydrogel contact lens\n\nfanfilcon A test lens: Silicone hydrogel contact lens'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '9.42', 'groupId': 'BG000'}, {'value': '32.7', 'spread': '9.00', 'groupId': 'BG001'}, {'value': '33.1', 'spread': '9.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-22', 'size': 17317510, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-11T12:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Subjects will be masked to lens type. Investigators will be unmasked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2019-08-07', 'resultsFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-24', 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Overall Comfort Rating', 'timeFrame': 'Two weeks', 'description': "Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses"}, {'measure': 'Subjective Overall Comfort Rating', 'timeFrame': 'Four weeks', 'description': "Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses"}], 'secondaryOutcomes': [{'measure': 'Average Wearing Time', 'timeFrame': 'Two weeks', 'description': 'Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes'}, {'measure': 'Average Wearing Time', 'timeFrame': 'Four weeks', 'description': 'Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes'}, {'measure': 'Average Comfortable Wearing Time', 'timeFrame': 'Two weeks', 'description': 'Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.'}, {'measure': 'Average Comfortable Wearing Time', 'timeFrame': 'Four weeks', 'description': 'Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.'}, {'measure': 'Lens Centration', 'timeFrame': 'Baseline (after 15 minutes)', 'description': 'Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\\>0.5mm)).'}, {'measure': 'Lens Centration', 'timeFrame': 'Two weeks', 'description': 'Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\\>0.5mm)).'}, {'measure': 'Lens Centration', 'timeFrame': 'Four weeks', 'description': 'Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\\>0.5mm)).'}, {'measure': 'Corneal Coverage', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)'}, {'measure': 'Corneal Coverage', 'timeFrame': 'Two weeks', 'description': 'Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)'}, {'measure': 'Corneal Coverage', 'timeFrame': 'Four weeks', 'description': 'Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)'}, {'measure': 'Post-Blink Movement', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)'}, {'measure': 'Post-Blink Movement', 'timeFrame': 'Two weeks', 'description': 'Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)'}, {'measure': 'Post-Blink Movement', 'timeFrame': 'Four weeks', 'description': 'Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)'}, {'measure': 'Lens Tightness - Push-up Test', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)'}, {'measure': 'Lens Tightness - Push-up Test', 'timeFrame': 'Two weeks', 'description': 'Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)'}, {'measure': 'Lens Tightness - Push-up Test', 'timeFrame': 'Four weeks', 'description': 'Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)'}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)'}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': 'Two weeks', 'description': 'Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)'}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': 'Four weeks', 'description': 'Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)'}, {'measure': 'Rating of Lens Surface Wettability', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).'}, {'measure': 'Rating of Lens Surface Wettability', 'timeFrame': 'Two weeks', 'description': 'Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).'}, {'measure': 'Rating of Lens Surface Wettability', 'timeFrame': 'Four weeks', 'description': 'Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).'}, {'measure': 'Presence of Film Deposits', 'timeFrame': 'Two weeks', 'description': 'Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).'}, {'measure': 'Presence of Film Deposits', 'timeFrame': 'Four weeks', 'description': 'Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).'}, {'measure': 'Number of White Spot Deposits', 'timeFrame': 'Two weeks', 'description': 'Number of white spot deposits assessed using slit lamp with white light, low medium magnification'}, {'measure': 'Number of White Spot Deposits', 'timeFrame': 'Four weeks', 'description': 'Number of white spot deposits assessed using slit lamp with white light, low medium magnification'}, {'measure': 'Primary Gaze Lag', 'timeFrame': 'Baseline (after 15 minutes of lens dispense)', 'description': 'Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)'}, {'measure': 'Primary Gaze Lag', 'timeFrame': 'Two weeks', 'description': 'Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)'}, {'measure': 'Primary Gaze Lag', 'timeFrame': 'Four weeks', 'description': 'Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 3 - 8:00am', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 3 - 12:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 3 - 4:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 3 - 8:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 7 - 8:00am', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 7 - 12:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 7 - 4:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 7 - 8:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 12 - 8:00am', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 12 - 12:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 12 - 4:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 12 - 8:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 26 - 8:00am', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 26 - 12:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 26 - 4:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}, {'measure': 'Comfort Throughout the Day', 'timeFrame': 'Day 26 - 8:00pm', 'description': 'Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.', 'detailedDescription': 'This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be a currently adapted soft contact lens wearer (\\>1 month of lens wear).\n* Be at least 18 years of age.\n* Refractive astigmatism \\<1.00D in both eyes.\n* Have clear corneas and be free of any anterior segment disorders.\n* Be correctable through spherocylindrical refraction to 20/25 or better in each eye.\n* Contact lens sphere requirement between -1.00D and -6.00D (inclusive).\n* Require visual correction in both eyes (monovision allowed, no monofit).\n* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:\n\n 1. No amblyopia\n 2. No strabismus\n 3. No evidence of lid abnormality or infection\n 4. No conjunctival abnormality or infection that would contraindicate contact lens wear\n 5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)\n 6. No other active ocular disease.\n* Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.\n* Willing to comply with the wear and study visit schedule.\n\nExclusion Criteria:\n\n* Using CooperVision Avaira Vitality, J\\&J Acuvue 2 or CooperVision Biomedics 55.\n* Require toric or multifocal contact lenses.\n* Previously shown a sensitivity to any of the study solution components.\n* Any systemic or ocular disease or allergies affecting ocular health.\n* Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.\n* Clinically significant (\\>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.\n* Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.\n* Keratoconus or other corneal irregularity.\n* Aphakia or amblyopia.\n* Have undergone corneal refractive surgery or any anterior segment surgery.\n* Abnormal lacrimal secretions.\n* Has diabetes.\n* Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).\n* History of chronic eye disease (e.g. glaucoma).\n* Pregnant or lactating or planning a pregnancy at the time of enrolment.\n* Participation in any concurrent clinical trial or in last 30 days."}, 'identificationModule': {'nctId': 'NCT04050618', 'briefTitle': 'Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear', 'orgStudyIdInfo': {'id': 'EX-MKTG-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ocufilcon D control lens, then fanfilcon A test lens', 'description': 'Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.', 'interventionNames': ['Device: fanfilcon A test lens', 'Device: ocufilcon D control lens']}, {'type': 'EXPERIMENTAL', 'label': 'etafilcon A controls, then fanfilcon A test lens', 'description': 'Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.', 'interventionNames': ['Device: fanfilcon A test lens', 'Device: etafilcon A control lens']}], 'interventions': [{'name': 'fanfilcon A test lens', 'type': 'DEVICE', 'otherNames': ['test lens', 'Avaira Vitality'], 'description': 'Silicone hydrogel contact lens', 'armGroupLabels': ['etafilcon A controls, then fanfilcon A test lens', 'ocufilcon D control lens, then fanfilcon A test lens']}, {'name': 'ocufilcon D control lens', 'type': 'DEVICE', 'otherNames': ['Biomedics 55 Premier', 'ocufilcon D (4-weekly) control lens'], 'description': 'hydrogel contact lens', 'armGroupLabels': ['ocufilcon D control lens, then fanfilcon A test lens']}, {'name': 'etafilcon A control lens', 'type': 'DEVICE', 'otherNames': ['etafilcon A (2-weekly) control lens', 'Acuvue 2'], 'description': 'hydrogel contact lens', 'armGroupLabels': ['etafilcon A controls, then fanfilcon A test lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90606', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Golden Optometric Group', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Vision Center PA (DBA Sabal Eye Care)', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Golden Vision', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Sacco Eye Group', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '75703', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Frazier Vision, Inc', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Office of William J. Bogus, O.D.', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'David C Ardaya, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Golden Optometric Group'}, {'name': 'William J Bogus, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Office of William J. Bogus, O.D.'}, {'name': 'Bryan E Frazier, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frazier Vision, Inc'}, {'name': 'Wayne Golden, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Golden Vision'}, {'name': 'Andrew J Sacco, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sacco Eye Group'}, {'name': 'Christopher Pearson, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Omega Vision Center PA (DBA Sabal Eye Care)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}