Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-04-08 @ 9:00 AM
Study NCT ID:
NCT02406495
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2015-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega@coopervision.com', 'phone': '(925) 621-3761', 'title': 'Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs', 'organization': 'Coopervision'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study.\n\nThere IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.\n\nThe investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to one week for each study lenses', 'eventGroups': [{'id': 'EG000', 'title': 'Overall Participants', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Visual Acuity - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'OD', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'OS', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Binocular', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Week', 'description': 'Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Comfort on insertion', 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Comfort prior to removal', 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Comfort overall', 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Week', 'description': 'Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit, Centration - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1 OD (Oculus Dexter)', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Filcon IV 1 OS (Oculus Sinister)', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG002', 'title': 'Ocufilcon D OD (Oculus Dexter)', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG003', 'title': 'Ocufilcon D OS (Oculus Sinister)', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': 'Decentration acceptable', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Decentration unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1 OD', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Filcon IV 1 OS', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG002', 'title': 'Ocufilcon D OD', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG003', 'title': 'Ocufilcon D OS', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': '0=Insufficient, unacceptable movement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '1=Minimal, but acceptable movement', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '2=Optimal movement', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': '3=Moderate, but acceptable movement', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': '4=Excessive, unacceptable movement', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.\n\n(Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'OD', 'categories': [{'measurements': [{'value': '49.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'OS', 'categories': [{'measurements': [{'value': '48.9', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.\n\nScale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement', 'unitOfMeasure': 'percentage of mean lens tightness', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1 OD', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Filcon IV 1 OS', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG002', 'title': 'Ocufilcon D OD', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG003', 'title': 'Ocufilcon D OS', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Should not be worn', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Borderline but acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Min. acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not perfect but OK', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Perfect', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Dryness during day', 'categories': [{'measurements': [{'value': '7.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Dryness prior to removal', 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Overall dryness', 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Week', 'description': 'Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Week', 'description': 'Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Week', 'description': 'Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Comfort', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Dryness', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Handling', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Vision', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Week', 'description': "Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Completely Satisfied', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Completely Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Completely Satisfied', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Completely Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Completely Satisfied', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Completely Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Completely Satisfied', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Completely Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV 1', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'classes': [{'title': 'Completely Satisfied', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Completely Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Participants', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Participants', 'description': 'Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.\n\nfilcon IV 1: contact lens\n\nocufilcon D: contact lens'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.92', 'spread': '5.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2015-03-30', 'resultsFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2015-03-30', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-30', 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Fit, Centration - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable'}, {'measure': 'Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.\n\n(Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).'}, {'measure': 'Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.\n\nScale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement'}, {'measure': 'Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).'}, {'measure': 'Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).'}, {'measure': 'Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).'}, {'measure': 'Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).'}, {'measure': 'Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).'}, {'measure': 'Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D', 'timeFrame': '1 Week', 'description': "Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D."}, {'measure': 'Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.'}, {'measure': 'Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.'}, {'measure': 'Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.'}, {'measure': 'Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.'}, {'measure': 'Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D', 'timeFrame': 'Baseline and 1 Week', 'description': 'Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia', 'Hyperopia']}, 'descriptionModule': {'briefSummary': 'Open label, 1-week daily disposable, dispensing study', 'detailedDescription': 'Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable 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 Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)\n* Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)\n* Has a spectacle cylinder up to 0.75D in each eye.\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* Is not a habitual wearer of Avaira sphere lenses\n* Has a CL prescription outside the range of the available parameters of the study lenses.\n* Has a spectacle cylinder ≥1.00D of cylinder in either eye.\n* Has a history of not achieving comfortable CL wear (5 days per week; \\> 8 hours/day)\n* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.\n* Presence of clinically significant (grade 2-4) anterior segment abnormalities\n* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.\n* Slit lamp findings that would contraindicate contact lens wear such as:\n\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': 'NCT02406495', 'briefTitle': 'Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week', 'orgStudyIdInfo': {'id': 'EX-MKTG-58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'filcon IV 1 and ocufilcon D', 'description': 'Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.', 'interventionNames': ['Device: filcon IV 1', 'Device: ocufilcon D']}], 'interventions': [{'name': 'filcon IV 1', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['filcon IV 1 and ocufilcon D']}, {'name': 'ocufilcon D', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['filcon IV 1 and ocufilcon D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46100', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Optometry Research Group (GIO) Optics Department, University of Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Robert Montés-Mico, OD MPhil PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optometry Research Group (GIO) Optics Department, University of Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}