Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-12 @ 6:38 AM
Study NCT ID:
NCT02185105
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2014-07-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pchamberlain@coopervision.com', 'phone': '9257306754', 'title': 'Sr. Manager, Clinical Research', 'organization': 'CooperVision, Inc'}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'Comfilcon A MTO', 'description': 'Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comfilcon A', 'description': 'Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A MTO: Randomized to a test lens in one eye and control lens in the other as a matched pair.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Surface Assessment of Study Lenses - Surface Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR (Extended Range) Toric', 'description': 'Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.'}, {'id': 'OG001', 'title': 'Comfilcon A Toric', 'description': 'Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15min & 6hrs', 'description': "Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Surface Assessment of Study Lenses - Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)', 'description': 'Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.'}, {'id': 'OG001', 'title': 'Comfilcon A Toric', 'description': 'Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15min & 6hrs', 'description': "Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film \\> 75% of surface)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Surface Assessment of Study Lenses - Surface Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)', 'description': 'Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.'}, {'id': 'OG001', 'title': 'Comfilcon A Toric', 'description': 'Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair.'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15min & 6hrs', 'description': "Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Rating For Comfort - Comfort Since Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '88', 'spread': '11', 'groupId': 'OG000'}, {'value': '90', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': '3 hours', 'categories': [{'measurements': [{'value': '84', 'spread': '17', 'groupId': 'OG000'}, {'value': '87', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '84', 'spread': '15', 'groupId': 'OG000'}, {'value': '88', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15min, 3hrs, 6hrs', 'description': "Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Rating For Comfort Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}, {'id': 'OG002', 'title': 'No Preference'}], 'classes': [{'title': '1 minute', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': '3 hours', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1min, 15min, 3hrs, 6hrs', 'description': "Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Rating For Handling - Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'spread': '7', 'groupId': 'OG000'}, {'value': '95', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 min', 'description': "Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Rating For Handling - Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '38', 'groupId': 'OG000'}, {'value': '74', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 min', 'description': "Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Investigator's Assessment of Stability", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '3', 'spread': '4', 'groupId': 'OG000'}, {'value': '3', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '3', 'spread': '3', 'groupId': 'OG000'}, {'value': '4', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15min & 6hrs', 'description': "Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.", 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'General Lens Fit - Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15min & 6hrs', 'description': "Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fitting - Rotation/Mislocation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1', 'spread': '5', 'groupId': 'OG000'}, {'value': '3', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '1', 'spread': '6', 'groupId': 'OG000'}, {'value': '1', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '2', 'spread': '5', 'groupId': 'OG000'}, {'value': '-1', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15min & 6hrs', 'description': "Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).", 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Ocular Health - Corneal Staining (Central)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comflicon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline & 6hrs', 'description': 'Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \\>45% of area)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Ocular Health - Corneal Staining (Nasal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comflicon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline & 6hrs', 'description': 'Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. 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(Scale 0-4, 0=No staining; 4= \\>45% of area)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Ocular Health - CornealStaining (Superior)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comflicon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline & 6hrs', 'description': 'Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. 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(Scale 0-4, 0=No staining; 4= \\>45% of area)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Ocular Health - Conjunctival Staining (Nasal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comflicon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline & 6hrs', 'description': 'Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. 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Scale: 0-4, (0=None; 4=Deep confluent).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Ocular Health - Conjunctival Staining (Temporal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comflicon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline & 6hrs', 'description': 'Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Ocular Health - Conjunctival Staining (Inferior)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comflicon A XR Toric (Extended Range)'}, {'id': 'OG001', 'title': 'Comfilcon A Toric'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline & 6hrs', 'description': 'Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric', 'description': 'Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric', 'description': 'Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.\n\ncomfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2014-07-07', 'resultsFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-03', 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Surface Assessment of Study Lenses - Surface Wettability', 'timeFrame': '15min & 6hrs', 'description': "Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)"}, {'measure': 'Lens Surface Assessment of Study Lenses - Deposits', 'timeFrame': '15min & 6hrs', 'description': "Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film \\> 75% of surface)"}, {'measure': 'Lens Surface Assessment of Study Lenses - Surface Acceptance', 'timeFrame': '15min & 6hrs', 'description': "Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)"}, {'measure': 'Subjective Rating For Comfort - Comfort Since Last Visit', 'timeFrame': '15min, 3hrs, 6hrs', 'description': "Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)"}, {'measure': 'Subjective Rating For Comfort Preference', 'timeFrame': '1min, 15min, 3hrs, 6hrs', 'description': "Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)"}, {'measure': 'Subjective Rating For Handling - Insertion', 'timeFrame': '1 min', 'description': "Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)"}, {'measure': 'Subjective Rating For Handling - Removal', 'timeFrame': '1 min', 'description': "Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)"}, {'measure': "Investigator's Assessment of Stability", 'timeFrame': '15min & 6hrs', 'description': "Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability."}, {'measure': 'General Lens Fit - Fit Acceptance', 'timeFrame': '15min & 6hrs', 'description': "Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)"}, {'measure': 'Lens Fitting - Rotation/Mislocation', 'timeFrame': 'Baseline, 15min & 6hrs', 'description': "Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-)."}, {'measure': 'Anterior Ocular Health - Corneal Staining (Central)', 'timeFrame': 'baseline & 6hrs', 'description': 'Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \\>45% of area)'}, {'measure': 'Anterior Ocular Health - Corneal Staining (Nasal)', 'timeFrame': 'baseline & 6hrs', 'description': 'Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \\>45% of area)'}, {'measure': 'Anterior Ocular Health - Corneal Staining (Temporal)', 'timeFrame': 'baseline & 6hrs', 'description': 'Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \\>45% of area)'}, {'measure': 'Anterior Ocular Health - CornealStaining (Superior)', 'timeFrame': 'baseline & 6hrs', 'description': 'Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \\>45% of area)'}, {'measure': 'Anterior Ocular Health - Corneal Staining (Inferior)', 'timeFrame': 'baseline & 6hrs', 'description': 'Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \\>45% of area)'}, {'measure': 'Anterior Ocular Health - Conjunctival Staining (Nasal)', 'timeFrame': 'baseline & 6hrs', 'description': 'Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).'}, {'measure': 'Anterior Ocular Health - Conjunctival Staining (Superior)', 'timeFrame': 'baseline & 6hrs', 'description': 'Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).'}, {'measure': 'Anterior Ocular Health - Conjunctival Staining (Temporal)', 'timeFrame': 'baseline & 6hrs', 'description': 'Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).'}, {'measure': 'Anterior Ocular Health - Conjunctival Staining (Inferior)', 'timeFrame': 'baseline & 6hrs', 'description': 'Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.', 'detailedDescription': 'Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has had a self-reported oculo-visual examination in the last two years.\n* Is at least 18 years of age and has full legal capacity to volunteer.\n* Has read and understood the information consent letter.\n* Is willing and able to follow instructions and maintain the appointment schedule.\n* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.\n* Currently wears soft contact lenses.\n* Has clear corneas and no active ocular disease.\n* Has not worn lenses for at least 12 hours before the examination\n\nExclusion Criteria:\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': 'NCT02185105', 'briefTitle': 'Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses', 'orgStudyIdInfo': {'id': 'CV-14-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'comfilcon A MTO', 'description': 'Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.', 'interventionNames': ['Device: comfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comfilcon A', 'description': 'Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.', 'interventionNames': ['Device: comfilcon A MTO']}], 'interventions': [{'name': 'comfilcon A MTO', 'type': 'DEVICE', 'otherNames': ['Biofinity Toric MTO'], 'description': 'Randomized to a test lens in one eye and control lens in the other as a matched pair.', 'armGroupLabels': ['comfilcon A']}, {'name': 'comfilcon A', 'type': 'DEVICE', 'otherNames': ['Biofinity Toric'], 'description': 'Randomized to a test lens in one eye and control lens in the other as a matched pair.', 'armGroupLabels': ['comfilcon A MTO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'CORL, Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}], 'overallOfficials': [{'name': 'Pete S Kollbaum, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}