Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04050605
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2019-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
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, O.D, MSc., FAAO', 'organization': 'CooperVision. Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to 4-weeks for each lens type, a total of 8-weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Somofilcon A Toric (Habitual) Lens', 'description': 'Participants are habitual wearers of somofilcon A toric lens for 4-weeks\n\nsomofilcon A toric contact lens: Contact Lens', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fanfilcon A Toric Contact Lens', 'description': 'Participants were refitted with fanfilcon A toric lens for 4-weeks\n\nfanfilcon A toric contact lens: Contact Lens', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Centration - Somofilcon A Toric (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks.\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration - Somofilcon A Toric (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks.\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric Lens', 'description': 'Participants were refitted with fanfilcon A toric lens.\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric Lens', 'description': 'Participants were refitted with fanfilcon A toric lens.\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-weeks', 'description': 'Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric Lens', 'description': 'Participants were refitted with fanfilcon A toric lens.\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-weeks', 'description': 'Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage - Somofilcon A Toric (Habitual ) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks.\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage - Somofilcon A Toric (Habitual ) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks..\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-weeks', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric Lens', 'description': 'Participants were refitted with fanfilcon A toric lens.\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric Lens', 'description': 'Participants were refitted with fanfilcon A toric lens.\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-weeks', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric Lens', 'description': 'Participants were refitted with fanfilcon A toric lens.\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-weeks', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement - Somofilcon A Toric (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks.\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement - Somofilcon A Toric (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4 weeks.\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 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'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric Lens', 'description': 'Participants were refitted with fanfilcon A toric lens.\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric Lens', 'description': 'Participants were refitted with fanfilcon A toric lens.\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks..\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks..\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'fanfilconA Toric', 'description': 'Participants were their refitted with fanfilcon A toric lens for 4-weeks..\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'fanfilconA Toric', 'description': 'Participants were their refitted with fanfilcon A toric lens for 4-weeks..\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'fanfilconA Toric', 'description': 'Participants were their refitted with fanfilcon A toric lens for 4-weeks..\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks..\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Wearing Time - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric', 'description': 'Participants were refitted with fanfilcon A toric lens for 4-weeks..\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Wearing Time - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric', 'description': 'Participants were refitted with fanfilcon A toric lens for 4-weeks..\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A Toric (Habitual)', 'description': 'Participants wore their habitual somofilcon A toric lens for 4-weeks..\n\nsomofilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Comfortable Wearing Time - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric', 'description': 'Participants were refitted with fanfilcon A toric lens for 4-weeks..\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Comfortable Wearing Time - Fanfilcon A Toric Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Toric', 'description': 'Participants were refitted with fanfilcon A toric lens for 4-weeks..\n\nfanfilcon A toric contact lens: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test)', 'description': 'Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.\n\nsomofilcon A toric contact lens: Contact Lens\n\nfanfilcon A toric contact lens: Contact Lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Somofilcon A Toric (Habitual), Then Fanfilcon Toric (Test)', 'description': 'Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.\n\nsomofilcon A toric contact lens: Contact Lens\n\nfanfilcon A toric contact lens: Contact Lens'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', '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': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-04', 'size': 1640837, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-05T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with preservative free sterile saline just prior to dispensing to maintain subject masking of the study lenses.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) will be dispensed and worn for 4-weeks for daily wear.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-04', 'studyFirstSubmitDate': '2019-08-07', 'resultsFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-13', 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Centration - Somofilcon A Toric (Habitual) Lens', 'timeFrame': 'Baseline', 'description': 'Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Centration - Somofilcon A Toric (Habitual) Lens', 'timeFrame': '4 weeks', 'description': 'Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Centration - Fanfilcon A Toric Lens', 'timeFrame': 'Baseline', 'description': 'Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Centration - Fanfilcon A Toric Lens', 'timeFrame': '2-weeks', 'description': 'Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Centration - Fanfilcon A Toric Lens', 'timeFrame': '4-weeks', 'description': 'Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Corneal Coverage - Somofilcon A Toric (Habitual ) Lens', 'timeFrame': 'Baseline', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Corneal Coverage - Somofilcon A Toric (Habitual ) Lens', 'timeFrame': '4-weeks', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Corneal Coverage - Fanfilcon A Toric Lens', 'timeFrame': 'Baseline', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Corneal Coverage - Fanfilcon A Toric Lens', 'timeFrame': '2-weeks', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Corneal Coverage - Fanfilcon A Toric Lens', 'timeFrame': '4-weeks', 'description': 'Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Post-Blink Movement - Somofilcon A Toric (Habitual) Lens', 'timeFrame': 'Baseline', 'description': 'Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)'}, {'measure': 'Post-Blink Movement - Somofilcon A Toric (Habitual) Lens', 'timeFrame': '4-weeks', 'description': 'Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).'}, {'measure': 'Post-Blink Movement - Fanfilcon A Toric Lens', 'timeFrame': 'Baseline', 'description': 'Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).'}, {'measure': 'Post-Blink Movement - Fanfilcon A Toric Lens', 'timeFrame': '2-weeks', 'description': 'Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).'}, {'measure': 'Post-Blink Movement - Fanfilcon A Toric Lens', 'timeFrame': '4-weeks', 'description': 'Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).'}, {'measure': 'Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens', 'timeFrame': 'Baseline', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).'}, {'measure': 'Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens', 'timeFrame': '4-weeks', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).'}, {'measure': 'Overall Lens Fit Acceptance - Fanfilcon A Toric Lens', 'timeFrame': 'Baseline', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).'}, {'measure': 'Overall Lens Fit Acceptance - Fanfilcon A Toric Lens', 'timeFrame': '2-weeks', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).'}, {'measure': 'Overall Lens Fit Acceptance - Fanfilcon A Toric Lens', 'timeFrame': '4-weeks', 'description': 'Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).'}], 'secondaryOutcomes': [{'measure': 'Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens', 'timeFrame': '4 weeks', 'description': 'Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.'}, {'measure': 'Average Daily Wearing Time - Fanfilcon A Toric Lens', 'timeFrame': '2 weeks', 'description': 'Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.'}, {'measure': 'Average Daily Wearing Time - Fanfilcon A Toric Lens', 'timeFrame': '4 weeks', 'description': 'Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.'}, {'measure': 'Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens', 'timeFrame': '4 weeks', 'description': 'Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day'}, {'measure': 'Average Comfortable Wearing Time - Fanfilcon A Toric Lens', 'timeFrame': '2 weeks', 'description': 'Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.'}, {'measure': 'Average Comfortable Wearing Time - Fanfilcon A Toric Lens', 'timeFrame': '4 weeks', 'description': 'Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.', 'detailedDescription': 'The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.\n\nThis is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is between 18 and 40 years of age (inclusive)\n* Has had a self-reported visual exam in the last two years\n* Is an adapted soft toric contact lens wearer\n* Has a contact lens spherical prescription between +6.00 to -8.00 (inclusive)\n* Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.\n* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.\n* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.\n* Has clear corneas and no active ocular disease\n* Has read, understood and signed the information consent letter.\n* Patient contact lens refraction should fit within the available parameters of the study lenses.\n* Is willing to comply with the wear schedule (at least 5 days per week, \\> 8 hours/day assuming there are no contraindications for doing so).\n* Is willing to comply with the visit schedule\n\nExclusion Criteria:\n\n* Has a CL prescription outside the range of the available parameters of the study lenses.\n* Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.\n* Has a history of not achieving comfortable CL wear (5 days per week; \\> 8 hours/day)\n* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.\n* Presence of clinically significant (grade 2-4) anterior segment abnormalities\n* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.\n* Slit lamp findings that would contraindicate contact lens wear such as:\n* Pathological dry eye or associated findings\n* Pterygium, pinguecula, or corneal scars within the visual axis\n* Neovascularization \\> 0.75 mm in from of the limbus\n* Giant papillary conjunctivitis (GCP) worse than grade 1\n* Anterior uveitis or iritis (past or present)\n* Seborrheic eczema, Seborrheic conjunctivitis\n* History of corneal ulcers or fungal infections\n* Poor personal hygiene\n* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)\n* Has aphakia, keratoconus or a highly irregular cornea.\n* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT04050605', 'briefTitle': 'Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear', 'orgStudyIdInfo': {'id': 'EX-MKTG-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'somofilcon A toric (habitual), then fanfilcon toric (test)', 'description': 'Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.', 'interventionNames': ['Device: somofilcon A toric contact lens', 'Device: fanfilcon A toric contact lens']}], 'interventions': [{'name': 'somofilcon A toric contact lens', 'type': 'DEVICE', 'otherNames': ['Habitual lens'], 'description': 'Contact Lens', 'armGroupLabels': ['somofilcon A toric (habitual), then fanfilcon toric (test)']}, {'name': 'fanfilcon A toric contact lens', 'type': 'DEVICE', 'otherNames': ['Test Lens'], 'description': 'Contact Lens', 'armGroupLabels': ['somofilcon A toric (habitual), then fanfilcon toric (test)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Optometry Clinic, National Autonomous University', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Ruben Velázquez Guerrero, MSc., FIACLE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Optometry, National Autonomous University (UNAM), Mexico City'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}