Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-10 @ 12:58 PM
Study NCT ID:
NCT03974802
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2019-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega@coopervision.com', 'phone': '9256213761', 'title': 'Jose A. Vega, O.D, MSc., FAAO', 'organization': 'CooperVision. Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to 4-weeks for each study lens', 'eventGroups': [{'id': 'EG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Subjects wore their habitual somofilcon A lens for 4 -weeks.\n\nsomofilcon A contact lens: Contact Lens', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fanfilcon A (Test) Lens', 'description': 'Subjects were refitted with fanfilcon A lens (test) for 4- weeks.\n\nfanfilcon A contact lens: Contact Lens', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Centration for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Decentartion Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4- weeks', 'description': 'Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A (Test) Lens', 'description': 'Participants were refitted with fanfilcon A test lens for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A (Test) Lens', 'description': 'Participants were refitted with fanfilcon A test lens for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-weeks', 'description': 'Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A (Test) Lens', 'description': 'Participants were refitted with fanfilcon A test lens for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Decentration Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4- weeks', 'description': 'Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Corneal Coverage for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Corneal Coverage for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: 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': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Corneal Coverage for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A (Test) Lens', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Corneal Coverage for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A (Test) Lens', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: 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': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Corneal Coverage for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A (Test) Lens', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: 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': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Lens Tightness for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Lens Tightness for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-Weeks', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Lens Tightness for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Lens Tightness for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-Weeks', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Lens Tightness for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-Weeks', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-Blink Movement for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.85', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 for Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.83', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.95', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.98', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.98', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Wearing Time - Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-weeks', 'description': 'Average daily wearing time for fanfilcon A (test) lens was measured in hours/day', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Wearing Time - Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-weeks', 'description': 'Average daily wearing time for fanfilcon A (test) lens was measured in hours/day', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A (Habitual) Lens', 'description': 'Participants wore their habitual somofilcon A lens for 4-weeks.\n\nsomofilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Comfortable Wearing Time - Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Comfortable Wearing Time - Fanfilcon A (Test) Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fanfilcon A Lens (Test)', 'description': 'Participants were refitted with fanfilcon A lens (test) for 4-weeks.\n\nfanfilcon A: Contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.', 'unitOfMeasure': 'hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Somofilcon A (Habitual) Lens, Then Fanfilcon A (Test) Lens', 'description': 'Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks.\n\nsomofilcon A contact lens: Contact Lens\n\nfanfilcon A contact lens: Contact Lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks.\n\nsomofilcon A contact lens: Contact Lens\n\nfanfilcon A contact lens: Contact Lens'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', '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': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26.1', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', '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': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-04', 'size': 6632207, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-14T17:57', '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 unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2019-06-03', 'resultsFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-06', 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Centration for Somofilcon A (Habitual) Lens', 'timeFrame': 'Baseline', 'description': 'Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Centration for Somofilcon A (Habitual) Lens', 'timeFrame': '4- weeks', 'description': 'Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Centration for Fanfilcon A (Test) Lens', 'timeFrame': 'Baseline', 'description': 'Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Centration for Fanfilcon A (Test) Lens', 'timeFrame': '2-weeks', 'description': 'Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Centration for Fanfilcon A (Test) Lens', 'timeFrame': '4- weeks', 'description': 'Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).'}, {'measure': 'Lens Corneal Coverage for Somofilcon A (Habitual) Lens', 'timeFrame': 'Baseline', 'description': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Lens Corneal Coverage for Somofilcon A (Habitual) Lens', 'timeFrame': '4 -weeks', 'description': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Lens Corneal Coverage for Fanfilcon A (Test) Lens', 'timeFrame': 'Baseline', 'description': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Lens Corneal Coverage for Fanfilcon A (Test) Lens', 'timeFrame': '2-weeks', 'description': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Lens Corneal Coverage for Fanfilcon A (Test) Lens', 'timeFrame': '4-weeks', 'description': 'Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)'}, {'measure': 'Percentage of Lens Tightness for Somofilcon A (Habitual) Lens', 'timeFrame': 'Baseline', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)'}, {'measure': 'Percentage of Lens Tightness for Somofilcon A (Habitual) Lens', 'timeFrame': '4-Weeks', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)'}, {'measure': 'Percentage of Lens Tightness for Fanfilcon A (Test) Lens', 'timeFrame': 'Baseline', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)'}, {'measure': 'Percentage of Lens Tightness for Fanfilcon A (Test) Lens', 'timeFrame': '2-Weeks', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)'}, {'measure': 'Percentage of Lens Tightness for Fanfilcon A (Test) Lens', 'timeFrame': '4-Weeks', 'description': 'Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)'}, {'measure': 'Post-Blink Movement for Somofilcon A (Habitual) Lens', 'timeFrame': 'Baseline', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)'}, {'measure': 'Post-Blink Movement for Somofilcon A (Habitual) Lens', 'timeFrame': '4-weeks', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)'}, {'measure': 'Post-Blink Movement for Fanfilcon A (Test) Lens', 'timeFrame': 'Baseline', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)'}, {'measure': 'Post-Blink Movement for Fanfilcon A (Test) Lens', 'timeFrame': '2-weeks', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)'}, {'measure': 'Post-Blink Movement for Fanfilcon A (Test) Lens', 'timeFrame': '4-weeks', 'description': 'Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)'}, {'measure': 'Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens', 'timeFrame': 'Baseline', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 for Somofilcon A (Habitual) Lens', 'timeFrame': '4-weeks', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens', 'timeFrame': 'Baseline', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens', 'timeFrame': '2-weeks', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens', 'timeFrame': '4-weeks', 'description': 'Overall fit acceptance was measured using a scale of 0-4 (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 (Habitual) Lens', 'timeFrame': '4-weeks', 'description': 'Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day'}, {'measure': 'Average Daily Wearing Time - Fanfilcon A (Test) Lens', 'timeFrame': '2-weeks', 'description': 'Average daily wearing time for fanfilcon A (test) lens was measured in hours/day'}, {'measure': 'Average Daily Wearing Time - Fanfilcon A (Test) Lens', 'timeFrame': '4-weeks', 'description': 'Average daily wearing time for fanfilcon A (test) lens was measured in hours/day'}, {'measure': 'Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens', 'timeFrame': '4 weeks', 'description': 'Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.'}, {'measure': 'Average Comfortable Wearing Time - Fanfilcon A (Test) Lens', 'timeFrame': '2 weeks', 'description': 'Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.'}, {'measure': 'Average Comfortable Wearing Time - Fanfilcon A (Test) Lens', 'timeFrame': '4 weeks', 'description': 'Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.', 'detailedDescription': 'The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.'}, '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 contact lens wearer\n* Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)\n* Have no less than -0.75D of astigmatism 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 of ≥ 1.00D 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\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': 'NCT03974802', 'briefTitle': 'Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear', 'orgStudyIdInfo': {'id': 'EX-MKTG-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'somofilcon A (habitual) lens, then fanfilcon A (test) lens', 'description': 'Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens.', 'interventionNames': ['Device: somofilcon A contact lens', 'Device: fanfilcon A contact lens']}], 'interventions': [{'name': 'somofilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['clariti elite', 'Habitual lens'], 'description': 'Contact Lens', 'armGroupLabels': ['somofilcon A (habitual) lens, then fanfilcon A (test) lens']}, {'name': 'fanfilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['Avaira Vitality', 'Test lens'], 'description': 'Contact Lens', 'armGroupLabels': ['somofilcon A (habitual) lens, then fanfilcon A (test) lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54090', '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'}}}}