Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-27 @ 8:53 PM
Study NCT ID:
NCT05741450
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2023-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Comparison of Two Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
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Vega OD, MSc, FAAO', 'organization': 'CooperVision, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The duration of the clinical trial, approximately 1.5 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Lens 1', 'description': 'All participants that received Lens 1', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lens 2', 'description': 'All participants that received Lens 2', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Overall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens 1', 'description': 'All participants that received Lens 1'}, {'id': 'OG001', 'title': 'Lens 2', 'description': 'All participants that received Lens 2'}], 'classes': [{'categories': [{'measurements': [{'value': '84.7', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '14.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from data analysis due to issues during lens application'}, {'type': 'SECONDARY', 'title': 'Subjective Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens 1', 'description': 'All participants that received Lens 1'}, {'id': 'OG001', 'title': 'Lens 2', 'description': 'All participants that received Lens 2'}], 'classes': [{'categories': [{'measurements': [{'value': '86.4', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '86.6', 'spread': '13.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from data analysis due to issues during lens application'}, {'type': 'SECONDARY', 'title': 'Subjective Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens 1', 'description': 'All participants that received Lens 1'}, {'id': 'OG001', 'title': 'Lens 2', 'description': 'All participants that received Lens 2'}], 'classes': [{'categories': [{'measurements': [{'value': '85.8', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '15.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was excluded from data analysis due to issues during lens application'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lens 1 (Monthly Replacement)', 'description': 'All participants wore Lens 1 for 15 minutes (Period 1)'}, {'id': 'FG001', 'title': 'Lens 2 (Daily Disposable)', 'description': 'All participants wore Lens 2 for 15 minutes (Period 2)'}], 'periods': [{'title': 'Period 1: Lens 1, 15 Minutes', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'comment': 'All participants received Lens 1 in Period 1.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2: Lens 2, 15 Minutes', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants received Lens 2 in Period 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'All participants who participated in the clinical trial.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32.4', 'spread': '11.9', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37.3', 'spread': '15.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age data is presented as stratified by the sex of the participant'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', '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.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-04', 'size': 1600181, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-14T16:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants received Lens 1 and then Lens 2 in fixed-sequence order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-02-14', 'resultsFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-18', 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Overall Score', 'timeFrame': '15 minutes', 'description': 'Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall'}], 'secondaryOutcomes': [{'measure': 'Subjective Comfort', 'timeFrame': '15 minutes', 'description': 'Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Causes pain, cannot be tolerated and 100=Excellent, cannot be felt'}, {'measure': 'Subjective Vision', 'timeFrame': '15 minutes', 'description': 'Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia', 'Hyperopia']}, 'descriptionModule': {'briefSummary': 'The study objective was to gather short-term clinical performance data for two soft contact lenses.', 'detailedDescription': 'The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* They are of legal age (18) and capacity to volunteer.\n* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.\n* They are willing and able to follow the protocol.\n* They currently wear soft contact lenses, or have done so within the past two years.\n* They are expected to be able to be fitted with the study lenses within the power range available.\n\nExclusion Criteria:\n\n* They have an ocular disorder which would normally contra-indicate contact lens wear.\n* They have a systemic disorder which would normally contra-indicate contact lens wear.\n* They are using any topical medication such as eye drops or ointment.\n* They are aphakic.\n* They have had corneal refractive surgery.\n* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.\n* They are pregnant or lactating.\n* They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.\n* They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.'}, 'identificationModule': {'nctId': 'NCT05741450', 'briefTitle': 'A Clinical Comparison of Two Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)', 'orgStudyIdInfo': {'id': 'C22-724 (EX-MKTG-138)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens 1', 'description': 'All participants wore Lens 1 for 15 minutes (Period 1)', 'interventionNames': ['Device: Lens 1 (monthly replacement)']}, {'type': 'EXPERIMENTAL', 'label': 'Lens 2', 'description': 'All participants wore Lens 2 for 15 minutes (Period 2)', 'interventionNames': ['Device: Lens 2 (daily disposable)']}], 'interventions': [{'name': 'Lens 1 (monthly replacement)', 'type': 'DEVICE', 'description': 'Monthly replacement spherical silicone hydrogel contact lens for 15 minutes', 'armGroupLabels': ['Lens 1']}, {'name': 'Lens 2 (daily disposable)', 'type': 'DEVICE', 'description': 'Daily disposable spherical silicone hydrogel contact lens for 15 minutes', 'armGroupLabels': ['Lens 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Eurolens Research', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Philip Morgan, PhD, MCOptom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurolens Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}