Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-04-13 @ 6:25 AM
Study NCT ID:
NCT02920957
Status:
COMPLETED
Last Update Posted:
2018-01-09
First Post:
2016-09-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega@coopervision.com', 'phone': '(925) 621-3761', 'title': 'Sr.Manager Global Medical Scientific Affairs', 'organization': 'CooperVision Inc'}, 'certainAgreement': {'otherDetails': 'Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Assessment of adverse events was performed during the study visits. Investigators may be notified of adverse events by the participants outside of the study visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Comfilcon A', 'description': 'Participants are randomized to wear the comfilcon A lens for one month during either as the first or second intervention.', 'otherNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Senofilcon C', 'description': 'Participants are randomized to wear the senofilcon C lens for one month during either as the first or second intervention.', 'otherNumAtRisk': 83, 'otherNumAffected': 0, 'seriousNumAtRisk': 83, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Motocycle Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Lens Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A at Dispense', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.\n\ncomfilcon A: contact lens'}, {'id': 'OG001', 'title': 'Comfilcon A After 2 Weeks', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.\n\ncomfilcon A: contact lens'}, {'id': 'OG002', 'title': 'Comfilcon A After 1 Month', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.\n\ncomfilcon A: contact lens'}, {'id': 'OG003', 'title': 'Senofilcon C at Dispense', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.\n\nsenofilcon C: contact lens'}, {'id': 'OG004', 'title': 'Senofilcon C After 2 Weeks', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.\n\nsenofilcon C: contact lens'}, {'id': 'OG005', 'title': 'Senofilcon C After 1 Month', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.\n\nsenofilcon C: contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'OG003'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'OG004'}, {'value': '3.3', 'spread': '0.8', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'description': 'Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A at Dispense', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG001', 'title': 'Comfilcon A After 2 Weeks', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG002', 'title': 'Comfilcon A After 1 Month', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG003', 'title': 'Senofilcon C at Dispense', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG004', 'title': 'Senofilcon C After 2 Weeks', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG005', 'title': 'Senofilcon C After 1 Month', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.'}, {'type': 'PRIMARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A at Dispense', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG001', 'title': 'Comfilcon A After 2 Weeks', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG002', 'title': 'Comfilcon A After 1 Month', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG003', 'title': 'Senofilcon C at Dispense', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG004', 'title': 'Senofilcon C After 2 Weeks', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG005', 'title': 'Senofilcon C After 1 Month', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '76', 'groupId': 'OG005'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Unacceptable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.'}, {'type': 'PRIMARY', 'title': 'Post-blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A at Dispense', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG001', 'title': 'Comfilcon A After 2 Weeks', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG002', 'title': 'Comfilcon A After 1 Month', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG003', 'title': 'Senofilcon C at Dispense', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG004', 'title': 'Senofilcon C After 2 Weeks', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG005', 'title': 'Senofilcon C After 1 Month', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '0.4', 'groupId': 'OG004'}, {'value': '1.8', 'spread': '0.6', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'description': 'Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.'}, {'type': 'PRIMARY', 'title': 'Lens Lag at Primary Gaze', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A at Dispense', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG001', 'title': 'Comfilcon A After 2 Weeks', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG002', 'title': 'Comfilcon A After 1 Month', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG003', 'title': 'Senofilcon C at Dispense', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG004', 'title': 'Senofilcon C After 2 Weeks', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG005', 'title': 'Senofilcon C After 1 Month', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG004'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'description': 'Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.'}, {'type': 'PRIMARY', 'title': 'Tightness on Push up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A at Dispense', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG001', 'title': 'Comfilcon A After 2 Weeks', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG002', 'title': 'Comfilcon A After 1 Month', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG003', 'title': 'Senofilcon C at Dispense', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG004', 'title': 'Senofilcon c After 2 Weeks', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG005', 'title': 'Senofilcon C After 1 Month', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '10', 'groupId': 'OG000'}, {'value': '51', 'spread': '9', 'groupId': 'OG001'}, {'value': '51', 'spread': '8', 'groupId': 'OG002'}, {'value': '54', 'spread': '9', 'groupId': 'OG003'}, {'value': '53', 'spread': '9', 'groupId': 'OG004'}, {'value': '53', 'spread': '9', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'description': 'Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.'}, {'type': 'PRIMARY', 'title': 'Lens Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A at Dispense', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG001', 'title': 'Comfilcon A After 2 Weeks', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG002', 'title': 'Comfilcon A After 1 Month', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG003', 'title': 'Senofilcon C at Dispense', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG004', 'title': 'Senofilcon C After 2 Weeks', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG005', 'title': 'Senofilcon C After 1 Month', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '3.3', 'spread': '0.7', 'groupId': 'OG004'}, {'value': '3.3', 'spread': '0.6', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'description': 'Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.'}, {'type': 'PRIMARY', 'title': 'Deposit Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A at Dispense', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG001', 'title': 'Comfilcon A After 2 Weeks', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG002', 'title': 'Comfilcon A After 1 Month', 'description': 'Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.'}, {'id': 'OG003', 'title': 'Senofilcon C at Dispense', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG004', 'title': 'Senofilcon C After 2 Weeks', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}, {'id': 'OG005', 'title': 'Senofilcon C After 1 Month', 'description': 'Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG004'}, {'value': '0.7', 'spread': '0.8', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'description': 'Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comfilcon A First Then Senofilcon C', 'description': 'Participants randomized to wear the comfilcon A lens first then crossover to Senofilcon C'}, {'id': 'FG001', 'title': 'Senofilcon C First Then Comfilcon A', 'description': 'Participants randomized to wear the senofilcon C lens first then crossover to comfilcon A'}], 'periods': [{'title': 'First Intervention : 1 Month', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention: 1 Month', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'There were 88 participants enrolled for this study, with 1 participant failed the screening leading to 87 who were fitted with and dispensed contact lenses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Baseline Characteristics', 'description': 'Includes groups randomized to wear comfilcon A lens first and senofilcon C lens first.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '27.9', 'spread': '4.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Entire Study Population'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2016-09-29', 'resultsFirstSubmitDate': '2017-10-09', 'studyFirstSubmitQcDate': '2016-09-29', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-11', 'studyFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Lens Fit Acceptance', 'timeFrame': 'Up to 1 month', 'description': 'Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.'}, {'measure': 'Corneal Coverage', 'timeFrame': 'Up to 1 month', 'description': 'Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)'}, {'measure': 'Lens Centration', 'timeFrame': 'Up to 1 month', 'description': 'Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)'}, {'measure': 'Post-blink Movement', 'timeFrame': 'Up to 1 month', 'description': 'Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)'}, {'measure': 'Lens Lag at Primary Gaze', 'timeFrame': 'Up to 1 month', 'description': 'Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)'}, {'measure': 'Tightness on Push up', 'timeFrame': 'Up to 1 month', 'description': 'Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)'}, {'measure': 'Lens Wettability', 'timeFrame': 'Up to 1 month', 'description': 'Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)'}, {'measure': 'Deposit Grading', 'timeFrame': 'Up to 1 month', 'description': 'Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.', 'detailedDescription': 'This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA person is eligible for inclusion in the study if he/she:\n\n* Is between 18 and 34 years of age (inclusive)\n* Has had a self-reported eye exam in the last two years\n* Is a spherical soft contact lens wearer\n* Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)\n* Has a spectacle cylinder no greater than 0.75D (Diopters) 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* Has a contact lens prescription that fits within the available parameters of the study lenses.\n* Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).\n* Is willing to comply with the visit schedule\n\nExclusion Criteria:\n\nA person will be excluded from the study if he/she:\n\n* Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; \\> 10 hours/day)\n* Presents with clinically significant anterior segment abnormalities\n* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.\n* Presents with slit lamp findings that would contraindicate contact lens wear such as:\n\n * Pathological dry eye or associated findings\n * Significant 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 (or history in past year)\n * Seborrheic eczema of eyelid region, 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.\n* Is habitually using rewetting/ lubricating eye drops more than once per day\n* Is currently wearing daily disposable lenses'}, 'identificationModule': {'nctId': 'NCT02920957', 'briefTitle': 'Performance Comparison Between Comfilcon A and Senofilcon C Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Performance Comparison Between Comfilcon A and Senofilcon C Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'comfilcon A', 'description': 'Participants are randomized to wear the comfilcon A lens for one month during the cross over study.', 'interventionNames': ['Device: comfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'senofilcon C', 'description': 'Participants are randomized to wear the senofilcon C lens for one month during the cross over study.', 'interventionNames': ['Device: senofilcon C']}], 'interventions': [{'name': 'comfilcon A', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['comfilcon A']}, {'name': 'senofilcon C', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['senofilcon C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90606', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Golden Optometric Group', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Coan Eye Care & Optical Boutique', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '55436', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Cornea & Contact Lens Institute of Minnesota', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Sacco Eye Group', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'Vision Professionals', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD, FAAO, FIACLE, FBCLA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre for Contact Lens Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}