Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT03519932
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega@coopervision.com', 'phone': '9256213761', 'title': 'Jose A.Vega OD, MSc., FAAO', 'organization': 'CooperVision Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'One month during each crossover period.', 'eventGroups': [{'id': 'EG000', 'title': 'Comfilcon A Toric', 'description': 'Subjects were randomized to wear comfilcon A toric lenses for 1-month and samfilcon A toric lenses for 1-month in this cross-over dispensing study.\n\nContact Lens: comfilcon A toric', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Samfilcon A Toric', 'description': 'Subjects were randomized to wear samfilcon A toric lenses for 1-month and comfilcon A toric lenses for 1-month in this cross-over dispensing study.\n\nContact Lens: samfilcon A toric', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort at Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Dispense', 'description': "Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Removal', 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': "Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use."}, {'type': 'PRIMARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Removal', 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-month', 'description': "Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Preference Based on Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Preference', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study for a month.\n\ncomfilcon A toric lens: Contact lens\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'title': 'Strongly prefer comfilcon A', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Slightly Prefer comfilcon A', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Slightly prefer samfilcon A', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Strongly prefer samfilcon A', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages may be rounded and therefore may not add up to equal to 100%'}, {'type': 'PRIMARY', 'title': 'Lens Preference Based on Overall Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Participants', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study for a month.\n\ncomfilcon A toric lens: Contact lens\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'title': 'Strongly prefer comfilcon A', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Slightly prefer comfilcon A', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Slightly prefer samfilcon A', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Strongly prefer samfilcon A', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '7.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Removal', 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use."}, {'type': 'PRIMARY', 'title': 'Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Removal', 'categories': [{'measurements': [{'value': '6.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-month', 'description': 'Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Dispense', 'description': 'Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use."}, {'type': 'SECONDARY', 'title': 'Ease of Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-month', 'description': 'Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.\n\ncomfilcon A toric lens: Contact lens\n\nsamfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.\n\ncomfilcon A toric lens: Contact lens\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use."}, {'type': 'SECONDARY', 'title': 'Ease of Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Toric Lens', 'description': 'Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study.\n\ncomfilcon A toric lens: Contact lens'}, {'id': 'OG001', 'title': 'Samfilcon A Toric Lens', 'description': 'Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study.\n\nsamfilcon A toric lens: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comfilcon A Toric Then Samfilcon A Toric', 'description': 'Subjects were randomized to wear comfilcon A toric lenses for 1-month and then crossover to wear Samfilcon A toric lenses for 1-month.\n\nContact Lens: comfilcon A toric Contact Lens: Samfilcon A toric'}, {'id': 'FG001', 'title': 'Samfilcon A Toric Then Comfilcon A Toric', 'description': 'Subjects were randomized to wear sammfilcon A toric lenses for 1-month and then crossover to wear comfilcon A toric lenses for 1-month.\n\nContact Lens: Samfilcon A toric Contact Lens: comfilcon A toric'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One subject had non-significant adverse event and data not included in the analysis', 'groupId': 'FG000', 'numSubjects': '23'}, {'comment': '3 subjects had non-significant adverse events and data not included in analysis.', 'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects who wore samfilcon A toric at 1st intervention wear comfilcon A toric at 2nd intervention', 'groupId': 'FG000', 'numSubjects': '22'}, {'comment': 'Subjects who wore comfilcon A toric at 1st intervention wear Samfilcon A toric at 2nd intervention', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Subjects were randomized to wear comfilcon A toric lenses for 1-month and samfilcon A toric lenses for 1-month in this cross-over dispensing study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Total Participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26.5', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-14', 'size': 3571422, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-11T17:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2018-05-01', 'resultsFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-17', 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort at Insertion', 'timeFrame': 'Dispense', 'description': "Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)"}, {'measure': 'Comfort', 'timeFrame': '2 weeks', 'description': "Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)"}, {'measure': 'Comfort', 'timeFrame': '1-month', 'description': "Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)"}, {'measure': 'Lens Preference Based on Overall Comfort', 'timeFrame': '1 month', 'description': 'Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)'}, {'measure': 'Lens Preference Based on Overall Dryness', 'timeFrame': '1 month', 'description': 'Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)'}, {'measure': 'Dryness', 'timeFrame': '2 weeks', 'description': 'Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)'}, {'measure': 'Dryness', 'timeFrame': '1-month', 'description': 'Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)'}], 'secondaryOutcomes': [{'measure': 'Ease of Insertion', 'timeFrame': 'Dispense', 'description': 'Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)'}, {'measure': 'Ease of Insertion', 'timeFrame': '2-weeks', 'description': 'Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)'}, {'measure': 'Ease of Insertion', 'timeFrame': '1-month', 'description': 'Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)'}, {'measure': 'Ease of Removal', 'timeFrame': '2-weeks', 'description': 'Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)'}, {'measure': 'Ease of Removal', 'timeFrame': '1 month', 'description': 'Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is at least 17 years of age and has full legal capacity to volunteer;\n* Has had a self-reported oculo-visual examination in the last two years.\n* Has read and signed an information consent letter;\n* Is willing and able to follow instructions and maintain the appointment schedule;\n* Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.\n* Is willing to wear contact lens in both eyes for the duration of the study;\n* Has a minimum astigmatism of - 0.75, determined by refraction;\n* Can be fit with the two study contact lens types in the powers available;\n* Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;\n* Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.\n* Has clear corneas and no active\\* ocular disease\n\nExclusion Criteria:\n\n* Is participating in any concurrent clinical trial;\n* Has any known active\\* ocular disease and/or infection;\n* Has a systemic condition that in the opinion of the investigator may affect a study measure;\n* Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;\n* Has known sensitivity to fluorescein dye or products to be used in the study;\n* Appears to have any active\\* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;\n* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);\n* Is aphakic;\n* Has undergone refractive error surgery.\n* Has participated in the PIANO (i.e. EX-MKTG-83) Study.'}, 'identificationModule': {'nctId': 'NCT03519932', 'briefTitle': 'Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism', 'orgStudyIdInfo': {'id': 'EX-MKTG-91'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'comfilcon A toric lens', 'description': 'Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.', 'interventionNames': ['Device: comfilcon A toric lens', 'Device: samfilcon A toric lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'samfilcon A toric lens', 'description': 'Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.', 'interventionNames': ['Device: comfilcon A toric lens', 'Device: samfilcon A toric lens']}], 'interventions': [{'name': 'comfilcon A toric lens', 'type': 'DEVICE', 'otherNames': ['Biofinity toric', 'test lens'], 'description': 'Contact lens', 'armGroupLabels': ['comfilcon A toric lens', 'samfilcon A toric lens']}, {'name': 'samfilcon A toric lens', 'type': 'DEVICE', 'otherNames': ['Ultra for Astigmatism', 'control lens'], 'description': 'Contact lens', 'armGroupLabels': ['comfilcon A toric lens', 'samfilcon A toric lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD FCOptom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Centre for Ocular Research & Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}