Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-03 @ 7:19 PM
Study NCT ID:
NCT02553395
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2015-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
One Week Assessment of The Phenacite Lens
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003261', 'term': 'Contact Lenses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PChamberlain@coopervision.com', 'phone': '925 730-6754', 'title': 'Paul Chamberlain', 'organization': 'CooperVision Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to one week on each study lens, a total of 2 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binocular Distance Visual Acuity (VA) - High Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - After 5 minutes of lens settling', 'description': 'Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Distance Visual Acuity (VA) -High Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Near Visual Acuity (VA) - High Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - after 5 minutes of lens dispense', 'description': 'Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Near Visual Acuity (VA) - High Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-week', 'description': 'Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (After 5 minutes of lens settling)', 'description': 'Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Near Visual Acuity (VA) - Low Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 5 minutes of lens settling)', 'description': 'Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Near Visual Acuity (VA) - Low Illumination High Contrast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1week', 'description': 'Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Ratings for Distance Quality of Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.'}], 'classes': [{'title': 'Phenacite Test Contact Lens', 'categories': [{'measurements': [{'value': '85', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'comfilcon A control lens', 'categories': [{'measurements': [{'value': '91', 'spread': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Ratings for Intermediate Quality of Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.'}], 'classes': [{'title': 'Phenacite Test Lens', 'categories': [{'measurements': [{'value': '91', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'comfilcon A control lens', 'categories': [{'measurements': [{'value': '95', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Ratings for Near Quality of Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.'}], 'classes': [{'title': 'Phenacite Test Lens', 'categories': [{'measurements': [{'value': '92', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'comfilcon A control lens', 'categories': [{'measurements': [{'value': '95', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post Blink Movement -', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'title': 'Right eye', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Left eye', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (After 5 minutes of lens dispense)', 'description': 'Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post Blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'title': 'Right eye', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Left Eye', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Push - Up Test for Lens Tightness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'title': 'Right eye', 'categories': [{'measurements': [{'value': '50.83', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '49.67', 'spread': '2.92', 'groupId': 'OG001'}]}]}, {'title': 'Left Eye', 'categories': [{'measurements': [{'value': '50.33', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '49.17', 'spread': '3.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (After 5 minutes of lens dispense)', 'description': 'Investigator assessment using Continuous Scale 0-100% (1% 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 Test for Lens Tightness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'title': 'Right Eye', 'categories': [{'measurements': [{'value': '50.33', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '49.17', 'spread': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'Left eye', 'categories': [{'measurements': [{'value': '49.33', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '49.17', 'spread': '2.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Investigator assessment using Continuous Scale 0-100% (1% 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': 'Lens Mobility Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'title': 'Right eye', 'categories': [{'measurements': [{'value': '2.97', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Left eye', 'categories': [{'measurements': [{'value': '2.97', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\\>1mm) on versions in all directions in 0.25 steps', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Mobility Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'title': 'Right Eye', 'categories': [{'measurements': [{'value': '2.98', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.04', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Left eye', 'categories': [{'measurements': [{'value': '3.02', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '3.04', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\\>1mm) on versions in all directions in 0.25 steps', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'title': 'Right Eye', 'categories': [{'measurements': [{'value': '3.48', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Left Eye', 'categories': [{'measurements': [{'value': '3.46', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '3.44', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (After 5 minutes of lens dispense)', 'description': "Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phenacite Contact Lens', 'description': 'Subjects were randomized to wear test contact lens for one week.\n\nPhenacite: Contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A Contact Lens', 'description': 'Subjects were randomized to wear control contact lens for one week.\n\ncomfilcon A: contact lens'}], 'classes': [{'title': 'Right eye', 'categories': [{'measurements': [{'value': '3.42', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '3.48', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Left Eye', 'categories': [{'measurements': [{'value': '3.35', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': "Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Lens Preference - Distance Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.'}], 'classes': [{'title': 'Phenacite Lens', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'comfilcon A', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Patient subjective preference: Phenacite lens, comfilcon A or No Preference', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Lens Preference -Overall Vision Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.'}], 'classes': [{'title': 'Phenacite', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'comfilcon A', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Patient subjective preference: Phenacite test lens, comfilcon A or No Preference', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Lens Preference - Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.'}], 'classes': [{'title': 'Phenacite', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'comfilcon A', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Patient subjective preference: Phenacite test lens, comfilcon A or No Preference', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Overall Lens Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.'}], 'classes': [{'title': 'Phenacite', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'comfilcon A', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phenacite Contact Lens Then Comfilcon A', 'description': 'Subjects were randomized to wear test lenses for one week and then cross-over to comfilcon A contact lens for one week.\n\nPhenacite : Contact Lens comfilcon A: contact lens'}, {'id': 'FG001', 'title': 'Comfilcon A Contact Lens Then Phenacite Contact Lens', 'description': 'Subjects were randomized to wear comfilcon A lenses for one week and then cross-over to test contact lens for one week.\n\ncomfilcon A: contact lens Phenacite : Contact Lens'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', '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': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2015-09-14', 'resultsFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-30', 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binocular Distance Visual Acuity (VA) - High Illumination High Contrast', 'timeFrame': 'Baseline - After 5 minutes of lens settling', 'description': 'Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)'}, {'measure': 'Binocular Distance Visual Acuity (VA) -High Illumination High Contrast', 'timeFrame': '1 week', 'description': 'Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)'}, {'measure': 'Binocular Near Visual Acuity (VA) - High Illumination High Contrast', 'timeFrame': 'Baseline - after 5 minutes of lens dispense', 'description': 'Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)'}, {'measure': 'Binocular Near Visual Acuity (VA) - High Illumination High Contrast', 'timeFrame': '1-week', 'description': 'Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)'}, {'measure': 'Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast', 'timeFrame': 'Baseline (After 5 minutes of lens settling)', 'description': 'Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)'}, {'measure': 'Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast', 'timeFrame': '1 week', 'description': 'Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)'}, {'measure': 'Binocular Near Visual Acuity (VA) - Low Illumination High Contrast', 'timeFrame': 'Baseline (after 5 minutes of lens settling)', 'description': 'Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)'}, {'measure': 'Binocular Near Visual Acuity (VA) - Low Illumination High Contrast', 'timeFrame': '1week', 'description': 'Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)'}, {'measure': 'Subjective Ratings for Distance Quality of Vision', 'timeFrame': '1 week', 'description': 'Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)'}, {'measure': 'Subjective Ratings for Intermediate Quality of Vision', 'timeFrame': '1 week', 'description': 'Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)'}, {'measure': 'Subjective Ratings for Near Quality of Vision', 'timeFrame': '1 week', 'description': 'Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)'}], 'secondaryOutcomes': [{'measure': 'Post Blink Movement -', 'timeFrame': 'Baseline (After 5 minutes of lens dispense)', 'description': 'Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)'}, {'measure': 'Post Blink Movement', 'timeFrame': '1 week', 'description': 'Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)'}, {'measure': 'Push - Up Test for Lens Tightness', 'timeFrame': 'Baseline (After 5 minutes of lens dispense)', 'description': 'Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement'}, {'measure': 'Push - Up Test for Lens Tightness', 'timeFrame': '1 week', 'description': 'Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement'}, {'measure': 'Lens Mobility Rating', 'timeFrame': 'Baseline (after 5 minutes of lens dispense)', 'description': 'Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\\>1mm) on versions in all directions in 0.25 steps'}, {'measure': 'Lens Mobility Rating', 'timeFrame': '1 week', 'description': 'Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\\>1mm) on versions in all directions in 0.25 steps'}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': 'Baseline (After 5 minutes of lens dispense)', 'description': "Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps"}, {'measure': 'Overall Lens Fit Acceptance', 'timeFrame': '1 week', 'description': "Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps"}, {'measure': 'Subjective Lens Preference - Distance Vision', 'timeFrame': '1 week', 'description': 'Patient subjective preference: Phenacite lens, comfilcon A or No Preference'}, {'measure': 'Subjective Lens Preference -Overall Vision Preference', 'timeFrame': '1 week', 'description': 'Patient subjective preference: Phenacite test lens, comfilcon A or No Preference'}, {'measure': 'Subjective Lens Preference - Comfort', 'timeFrame': '1 week', 'description': 'Patient subjective preference: Phenacite test lens, comfilcon A or No Preference'}, {'measure': 'Subjective Overall Lens Preference', 'timeFrame': '1 week', 'description': 'Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance.\n\nThe study test lens was not the final optical design and the study results were not used for the design validation.', 'detailedDescription': 'This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.\n\nThe study test lens was not the final optical design and the study results were not used for the design validation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A person is eligible for inclusion in the study if he/she:\n\n * Oculo-visual examination in the last two years\n * Between 18 and 35 years of age and has full legal capacity to volunteer\n * Has read and understood the informed consent letter\n * Is willing and able to follow instructions and maintain the appointment schedule\n * Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected\n * Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopter) and -4.50D\n * Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder \\<-0.75\n * Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period\n * Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.\n\nExclusion Criteria:\n\n* A person will be excluded from the study if he/she:\n\n * Has never worn contact lenses before.\n * Has any systemic disease affecting ocular health.\n * Is using any systemic or topical medications that will affect ocular health.\n * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.\n * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.\n * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.\n * Is aphakic.\n * Has undergone corneal refractive surgery.\n * Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT02553395', 'briefTitle': 'One Week Assessment of The Phenacite Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'One Week Assessment of The Phenacite Lens', 'orgStudyIdInfo': {'id': 'CV-15-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenacite contact lens', 'description': 'Study Test Contact Lens', 'interventionNames': ['Device: Phenacite (Test) contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comfilcon A contact lens', 'description': 'Control Contact Lens', 'interventionNames': ['Device: comfilcon A contact lens']}], 'interventions': [{'name': 'Phenacite (Test) contact lens', 'type': 'DEVICE', 'armGroupLabels': ['Phenacite contact lens']}, {'name': 'comfilcon A contact lens', 'type': 'DEVICE', 'armGroupLabels': ['comfilcon A contact lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}], 'overallOfficials': [{'name': 'Peter Kollbaum, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Optics Research Lab (CORL)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}