Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT04195893
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2019-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega@coopervision.com', 'phone': '9256213761', 'title': 'Jose A. Vega, O.D, MSc., FAAO', 'organization': 'CooperVision. Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From baseline till 1 -week for each type of lenses, up to 2 weeks total', 'eventGroups': [{'id': 'EG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 2, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjuctival Staining', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Handling for Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Handling for Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Handling for Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': 'Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Handling for Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Week', 'description': 'Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Handling for Lens Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Handling for Lens Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Handling for Lens Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': 'Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Handling for Lens Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 10 minutes of lens fitting)', 'description': 'Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive \\& occasionally encroaching limbus)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive \\& occasionally encroaching limbus)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 10 minutes of lens fitting)', 'description': 'Post-blink movement in primary gaze, in 0.1mm steps', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 -week', 'description': 'Post-blink movement in primary gaze, in 0.1mm steps', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Push-up Tightness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '5', 'groupId': 'OG000'}, {'value': '49', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 10 minutes of lens fitting)', 'description': 'Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Push-up Tightness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '6', 'groupId': 'OG000'}, {'value': '48', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Ratings of Comfort After Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Ratings of Comfort After Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Ratings of Comfort After Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Ratings of Comfort After Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subjective Ratings of Comfort After Lens Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens'}, {'id': 'OG001', 'title': 'Etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-Week', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Somofilcon A Then Etafilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.\n\nsomofilcon A: Contact Lens etafilcon A: Contact Lens'}, {'id': 'FG001', 'title': 'Etafilcon A Then Somofilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.\n\netafilcon A: Contact Lens somofilcon A: Contact Lens'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Total Participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '56', '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': '56', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46', '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': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-02', 'size': 9354429, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-09T20:43', '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': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2019-12-10', 'resultsFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-14', 'studyFirstPostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjective Ratings of Comfort After Lens Insertion', 'timeFrame': 'Baseline', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses)."}, {'measure': 'Subjective Ratings of Comfort After Lens Insertion', 'timeFrame': '1 Day', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses)."}, {'measure': 'Subjective Ratings of Comfort After Lens Insertion', 'timeFrame': 'Day 3', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses)."}, {'measure': 'Subjective Ratings of Comfort After Lens Insertion', 'timeFrame': 'Day 5', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses)."}, {'measure': 'Subjective Ratings of Comfort After Lens Insertion', 'timeFrame': '1-Week', 'description': "Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses)."}], 'primaryOutcomes': [{'measure': 'Lens Handling for Lens Insertion', 'timeFrame': 'Day 1', 'description': 'Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)'}, {'measure': 'Lens Handling for Lens Insertion', 'timeFrame': 'Day 3', 'description': 'Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)'}, {'measure': 'Lens Handling for Lens Insertion', 'timeFrame': 'Day 5', 'description': 'Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)'}, {'measure': 'Lens Handling for Lens Insertion', 'timeFrame': '1 Week', 'description': 'Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)'}, {'measure': 'Lens Handling for Lens Removal', 'timeFrame': 'Day 1', 'description': 'Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)'}, {'measure': 'Lens Handling for Lens Removal', 'timeFrame': 'Day 3', 'description': 'Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)'}, {'measure': 'Lens Handling for Lens Removal', 'timeFrame': 'Day 5', 'description': 'Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)'}, {'measure': 'Lens Handling for Lens Removal', 'timeFrame': '1 week', 'description': 'Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)'}], 'secondaryOutcomes': [{'measure': 'Lens Centration', 'timeFrame': 'Baseline (after 10 minutes of lens fitting)', 'description': 'Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive \\& occasionally encroaching limbus)'}, {'measure': 'Lens Centration', 'timeFrame': '1 week', 'description': 'Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive \\& occasionally encroaching limbus)'}, {'measure': 'Post-blink Movement', 'timeFrame': 'Baseline (after 10 minutes of lens fitting)', 'description': 'Post-blink movement in primary gaze, in 0.1mm steps'}, {'measure': 'Post-blink Movement', 'timeFrame': '1 -week', 'description': 'Post-blink movement in primary gaze, in 0.1mm steps'}, {'measure': 'Push-up Tightness', 'timeFrame': 'Baseline (after 10 minutes of lens fitting)', 'description': 'Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)'}, {'measure': 'Push-up Tightness', 'timeFrame': '1 week', 'description': 'Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.', 'detailedDescription': 'The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will only be eligible for the study if:\n\n 1. Is at least 17 years of age and has full legal capacity to volunteer;\n 2. Has read and signed an information consent letter;\n 3. Is willing and able to follow instructions and maintain the appointment schedule;\n 4. Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;\n 5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;\n 6. Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;\n 7. Demonstrates an acceptable fit with the study lenses;\n 8. Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.\n\n Exclusion Criteria:\n* Subjects will not be eligible to take part in the study if:\n\n 1. Is participating in any concurrent clinical or research study;\n 2. Has any known active\\* ocular disease and/or infection;\n 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;\n 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;\n 5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;\n 6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);\n 7. Is aphakic;\n 8. Has undergone refractive error surgery;\n 9. Is an employee of the Centre for Ocular Research \\& Education;\n 10. Has participated in the BEAGLE (EX-MKTG-104) study.'}, 'identificationModule': {'nctId': 'NCT04195893', 'briefTitle': 'Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)', 'orgStudyIdInfo': {'id': 'EX-MKTG-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.', 'interventionNames': ['Device: somofilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'etafilcon A', 'description': 'Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.', 'interventionNames': ['Device: etafilcon A']}], 'interventions': [{'name': 'somofilcon A', 'type': 'DEVICE', 'otherNames': ['Clariti 1-Day'], 'description': 'Contact Lens', 'armGroupLabels': ['somofilcon A']}, {'name': 'etafilcon A', 'type': 'DEVICE', 'otherNames': ['1-Day Acuvue Moist'], 'description': 'Contact Lens', 'armGroupLabels': ['etafilcon A']}]}, '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', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}