Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT03006458
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2016-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses
Sponsor:
Organization:
Raw JSON
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{'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Unsatisfied Vision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Total Participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.2', 'spread': '6.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-02', 'size': 1679598, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-29T17:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2019-12-19', 'completionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2016-12-27', 'dispFirstSubmitQcDate': '2019-12-19', 'resultsFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2016-12-27', 'dispFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-15', 'studyFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stability', 'timeFrame': 'Baseline', 'description': "Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational."}, {'measure': 'Stability', 'timeFrame': '2 weeks', 'description': "Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational."}, {'measure': 'Overall Toric Lens Fit Acceptance', 'timeFrame': 'Baseline', 'description': "Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum."}, {'measure': 'Overall Toric Lens Fit Acceptance', 'timeFrame': '2 weeks', 'description': "Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum."}, {'measure': 'Comfort', 'timeFrame': 'Baseline', 'description': 'Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever'}, {'measure': 'Comfort', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever'}, {'measure': 'Overall Satisfaction', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied'}, {'measure': 'Dryness', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time'}, {'measure': 'Visual Fluctuation/ Stability', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing'}, {'measure': 'Handling', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy'}, {'measure': 'Quality of Near Vision', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.'}, {'measure': 'Quality of Intermediate Vision', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.'}, {'measure': 'Quality of Distance Vision', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.'}, {'measure': 'Quality of Vision While Driving During the Day', 'timeFrame': '2 weeks', 'description': 'Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.'}, {'measure': 'Quality of Vision While Driving During the Night', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.'}, {'measure': 'Ghosting at Near', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.'}, {'measure': 'Ghosting at Distance', 'timeFrame': '2 weeks', 'description': 'Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.', 'detailedDescription': 'This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Thirty subjects will use each lens type for two weeks in random sequence. Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn on a daily wear basis.\n\nThe final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will only be eligible for the study if:\n\n 1. They are aged 40 - 70 years, inclusive.\n 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.\n 3. They are willing and able to follow the protocol.\n 4. They have successfully completed the non-dispensing study (C16-597) as the lenses to be worn on this study (C16-599) are predetermined from their participation on study C16-597.\n 5. They have a contact lens spherical prescription between +10.00 to -10.00D (Diopters) (inclusive).\n 6. They have astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.\n 7. They have an Add component to their spectacle refraction (between +0.75 and\n\n +2.50DS).\n 8. They can be satisfactorily fitted with the study lenses.\n 9. They can attain at least 0.30 logMAR binocular distance high contrast visual acuity with the study lenses within the available power range.\n 10. They have successfully worn soft contact lenses in the last two years.\n 11. They are willing to comply with the wear schedule (at least five days per week and for at least six hours per day).\n 12. They agree not to participate in other clinical research for the duration of this study.\n 13. They own a wearable pair of spectacles.\n\nExclusion Criteria:\n\n* Subjects will not be eligible to take part in the study if:\n\n 1. They have an ocular disorder which would normally contra-indicate contact lens wear.\n 2. They have a systemic disorder which would normally contra-indicate contact lens wear.\n 3. They are using any topical medication such as eye drops or ointment.\n 4. They have had cataract surgery.\n 5. They have had corneal refractive surgery.\n 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.\n 7. They are pregnant or breast-feeding.\n 8. They have any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the Efron classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.\n 9. They have any infectious disease (e.g. hepatitis) which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV).\n 10. They have a history of anaphylaxis or severe allergic reaction.\n 11. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.'}, 'identificationModule': {'nctId': 'NCT03006458', 'briefTitle': 'A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'A Clinical Comparison of the Comfilcon A (Extended Range) XR Toric Multifocal and Omafilcon B Toric XR Multifocal Contact Lenses', 'orgStudyIdInfo': {'id': 'CV-16-28 (C16-599)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'comfilcon A', 'description': 'Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.\n\nThe final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.', 'interventionNames': ['Device: comfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'omafilcon B', 'description': 'Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.', 'interventionNames': ['Device: omafilcon B']}], 'interventions': [{'name': 'comfilcon A', 'type': 'DEVICE', 'description': 'toric contact lens', 'armGroupLabels': ['comfilcon A']}, {'name': 'omafilcon B', 'type': 'DEVICE', 'description': 'toric contact lens', 'armGroupLabels': ['omafilcon B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9PL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Eurolens Research', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}