Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-03-14 @ 6:55 AM
Study NCT ID:
NCT02815735
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2016-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-Centre Clinical Evaluation of Two Reusable Soft Contact 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': 'Senior Manager Global Medical Scientific Affairs', 'organization': 'CooperVision Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Comfilcon A', 'description': 'Participants wear comfilcon A lens for 4 weeks during the cross over study.\n\ncomfilcon A: contact lens', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lotrafilcon B', 'description': 'Participants wear lotrafilcon B lens for 4 weeks during the cross over study.\n\nlotrafilcon B: contact lens', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual (Baseline)', 'description': 'Habitual data assessed at baseline.'}, {'id': 'OG001', 'title': 'Comfilcon A (2 Weeks)', 'description': 'Participants wear comfilcon A lens for 4 weeks during the cross over study.\n\ncomfilcon A: contact lens'}, {'id': 'OG002', 'title': 'Lotrafilcon B (2 Weeks)', 'description': 'Participants wear lotrafilcon B lens for 4 weeks during the cross over study.\n\nlotrafilcon B: contact lens'}, {'id': 'OG003', 'title': 'Comfilcon A (4 Weeks)', 'description': 'Participants wear comfilcon A lens for 4 weeks during the cross over study.\n\ncomfilcon A: contact lens'}, {'id': 'OG004', 'title': 'Lotrafilcon B (4 Weeks)', 'description': 'Participants wear lotrafilcon B lens for 4 weeks during the cross over study.\n\nlotrafilcon B: contact lens'}], 'classes': [{'title': 'Comfort on insertion', 'categories': [{'measurements': [{'value': '8.90', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '9.03', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '8.70', 'spread': '1.57', 'groupId': 'OG002'}, {'value': '8.74', 'spread': '1.25', 'groupId': 'OG003'}, {'value': '8.60', 'spread': '1.62', 'groupId': 'OG004'}]}]}, {'title': 'Overall comfort', 'categories': [{'measurements': [{'value': '8.86', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '8.13', 'spread': '1.69', 'groupId': 'OG001'}, {'value': '8.43', 'spread': '1.54', 'groupId': 'OG002'}, {'value': '8.11', 'spread': '1.57', 'groupId': 'OG003'}, {'value': '8.24', 'spread': '1.65', 'groupId': 'OG004'}]}]}, {'title': 'End-of-Day Comfort', 'categories': [{'measurements': [{'value': '8.03', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '7.31', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '7.45', 'spread': '2.23', 'groupId': 'OG002'}, {'value': '7.23', 'spread': '2.17', 'groupId': 'OG003'}, {'value': '7.34', 'spread': '2.34', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, 4 weeks', 'description': "Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comfort During the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A (Day 3)', 'description': 'Participants wear comfilcon A lens for 4 weeks during the cross over study.\n\ncomfilcon A: contact lens'}, {'id': 'OG001', 'title': 'Lotrafilcon B (Day 3)', 'description': 'Participants wear lotrafilcon B lens for 4 weeks during the cross over study.\n\nlotrafilcon B: contact lens'}, {'id': 'OG002', 'title': 'Comfilcon A (Day 12)', 'description': 'Participants wear comfilcon A lens for 4 weeks during the cross over study.\n\ncomfilcon A: contact lens'}, {'id': 'OG003', 'title': 'Lotrafilcon B (Day 12)', 'description': 'Participants wear lotrafilcon B lens for 4 weeks during the cross over study.\n\nlotrafilcon B: contact lens'}, {'id': 'OG004', 'title': 'Comfilcon A (Day 26)', 'description': 'Participants wear comfilcon A lens for 4 weeks during the cross over study.\n\ncomfilcon A: contact lens'}, {'id': 'OG005', 'title': 'Lotrafilcon B (Day 26)', 'description': 'Participants wear lotrafilcon B lens for 4 weeks during the cross over study.\n\nlotrafilcon B: contact lens'}], 'classes': [{'title': '8:00 am', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.98', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '8.78', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '8.67', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '8.96', 'spread': '1.26', 'groupId': 'OG003'}, {'value': '8.78', 'spread': '1.00', 'groupId': 'OG004'}, {'value': '8.59', 'spread': '1.48', 'groupId': 'OG005'}]}]}, {'title': '12:00 pm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.94', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '8.95', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '8.59', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '8.73', 'spread': '1.41', 'groupId': 'OG003'}, {'value': '8.72', 'spread': '1.39', 'groupId': 'OG004'}, {'value': '8.60', 'spread': '1.32', 'groupId': 'OG005'}]}]}, {'title': '4:00 pm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.51', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '8.74', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '8.51', 'spread': '1.49', 'groupId': 'OG002'}, {'value': '8.70', 'spread': '1.45', 'groupId': 'OG003'}, {'value': '8.31', 'spread': '1.56', 'groupId': 'OG004'}, {'value': '8.27', 'spread': '1.62', 'groupId': 'OG005'}]}]}, {'title': '8:00 pm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.15', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '8.14', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '7.91', 'spread': '1.89', 'groupId': 'OG002'}, {'value': '8.25', 'spread': '1.77', 'groupId': 'OG003'}, {'value': '7.85', 'spread': '1.70', 'groupId': 'OG004'}, {'value': '7.89', 'spread': '1.92', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 3, 12, 26', 'description': "Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data from one participant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comfilcon A, Then Lotrafilcon B', 'description': 'Participants wear comfilcon A lens, then lotrafilcon B for 4 weeks during the cross over study.\n\ncomfilcon A: contact lens\n\nlotrafilcon B: contact lens'}, {'id': 'FG001', 'title': 'Lotrafilcon B, Then Comfilcon A', 'description': 'Participants wear lotrafilcon B lens, then comfilcon A lens for 4 weeks during the cross over study.\n\nlotrafilcon B: contact lens\n\ncomfilcon A: contact lens'}], 'periods': [{'title': 'First Intervention (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Discomfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Poor fitting characteristics', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Four subjects were not dispensed lenses due to screen failure. Seven subjects discontinued from the study due to the investigational site withdrawing from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Participants', 'description': 'Participants wear comfilcon A and lotrafilcon B lens for 4 weeks during the cross over study.\n\ncomfilcon A: contact lens\n\nlotrafilcon B: contact lens'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '4.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2016-06-24', 'resultsFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-28', 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort', 'timeFrame': 'Baseline, 2 weeks, 4 weeks', 'description': "Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses."}, {'measure': 'Comfort During the Day', 'timeFrame': 'Days 3, 12, 26', 'description': "Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.', 'detailedDescription': 'This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)\n* Adapted soft CL wearers (i.e. \\>1 month) who are reusable lens wearers\\*\n* Spectacle cylinder 0.75D in both eyes\n* Correctable to 6/9 in both eyes\n* Be between 18 and 34 years of age (inclusive)\n* Able to read, comprehend and sign an informed consent\n* Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm\n* Willing to comply with the wear and study visit schedule\n\nExclusion Criteria:\n\nAny of the following will render a subject ineligible for inclusion:\n\n* Existing wearer of daily disposable contact lenses\n* Known allergy to Opti-Free PureMoist multipurpose solution\n* Any active corneal infection, injury or inflammation\n* Systemic or ocular allergies, which might interfere with CL wear\n* Systemic disease, which might interfere with CL wear\n* Ocular disease, which might interfere with CL wear\n* Strabismus or amblyopia\n* Subjects who have undergone corneal refractive surgery\n* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear\n* Pregnant, planning a pregnancy or lactating\n* Use of systemic/topical medication contraindicating CL wear\n* Diabetic\n* Site employees or family members of investigators\n* Participation in any concurrent trial or in the last 30 days'}, 'identificationModule': {'nctId': 'NCT02815735', 'briefTitle': 'Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-68 (VISA-407)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'comfilcon A', 'description': 'Participants wear comfilcon A lens for 4 weeks during the cross over study.', 'interventionNames': ['Device: comfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lotrafilcon B', 'description': 'Participants wear lotrafilcon B lens for 4 weeks during the cross over study.', 'interventionNames': ['Device: lotrafilcon B']}], 'interventions': [{'name': 'comfilcon A', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['comfilcon A']}, {'name': 'lotrafilcon B', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['lotrafilcon B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG1 1EX', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Eyesite', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'BS40 8PR', 'city': 'Chew Magna', 'state': 'Bristol', 'country': 'United Kingdom', 'facility': 'Brock and Houlford', 'geoPoint': {'lat': 51.36611, 'lon': -2.61028}}, {'zip': 'BH18 8DP', 'city': 'Broadstone', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': "Tempany's Boutique Opticians", 'geoPoint': {'lat': 50.75717, 'lon': -1.99406}}, {'zip': 'CF24 3RQ', 'city': 'Cardiff', 'state': 'Glamorgan', 'country': 'United Kingdom', 'facility': 'Chalmers Opticians', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'AL1 3LH', 'city': 'St Albans', 'state': 'Hertfordshire', 'country': 'United Kingdom', 'facility': 'Leightons', 'geoPoint': {'lat': 51.75, 'lon': -0.33333}}, {'zip': 'BB4 7QN', 'city': 'Rawtenstall', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'David Gould Opticians', 'geoPoint': {'lat': 53.70076, 'lon': -2.28442}}, {'zip': 'UB8 1JX', 'city': 'Uxbridge', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Harrold Opticians', 'geoPoint': {'lat': 51.5489, 'lon': -0.48211}}, {'zip': 'B4 7TB', 'city': 'Birmingham', 'state': 'Warwickshire', 'country': 'United Kingdom', 'facility': 'Boots Opticians Ltd', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'GU9 7EN', 'city': 'Farnham', 'country': 'United Kingdom', 'facility': 'Visioncare Research Ltd.', 'geoPoint': {'lat': 51.21444, 'lon': -0.80054}}], 'overallOfficials': [{'name': 'Graeme Young', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Visioncare Research Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}