Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-04 @ 4:47 PM
Study NCT ID:
NCT06431061
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2024-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Proclear Toric and Biofinity Toric
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JVega2@coopervision.com', 'phone': '925-621-3761', 'title': 'Jose A Vega, OD,MSc,PhD', 'organization': 'CooperVision Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, approximately 23 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Lens A (Omafilcon B)', 'description': 'All participants wore lens A for 15 minutes (Period 1).\n\nLens A (omafilcon B): 15 minutes of daily wear.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lens B (Comfilcon A)', 'description': 'All participants wore lens B for 15 minutes (Period 2).\n\nLens B (comfilcon A): 15 minutes of daily wear.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens A (Omafilcon B)', 'description': 'All participants wore lens A for 15 minutes (Period 1).\n\nLens A (omafilcon B): 15 minutes of daily wear.'}, {'id': 'OG001', 'title': 'Lens B (Comfilcon A)', 'description': 'All participants wore lens B for 15 minutes (Period 2).\n\nLens B (comfilcon A): 15 minutes of daily wear.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 15 minutes of continuous wear', 'description': 'Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)', 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All the participants who were eligible in the study were included in the analysis. (n=37)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lens A (Omafilcon B)', 'description': 'All participants wore lens A for 15 minutes (Period 1).\n\nLens A (omafilcon B): 15 minutes of daily wear.'}, {'id': 'FG001', 'title': 'Lens B (Comfilcon A)', 'description': 'All participants wore lens B for 15 minutes (Period 2).\n\nLens B (comfilcon A): 15 minutes of daily wear.'}], 'periods': [{'title': 'Period 1: Lens A (15 Minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'comment': 'All participants received Lens A in Period 1.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2: Lens B (15 Minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants received Lens B in Period 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Thirty-eight Participants were screened. One Participant was not eligible due to screening failure.\n\nAll the participants who were eligible in the study were included in the analysis. (n=37)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Includes all Study Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.6', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', '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': '2024-05-01', 'size': 2653616, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-02T18:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2024-05-22', 'resultsFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-11', 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Fit Acceptance', 'timeFrame': 'After 15 minutes of continuous wear', 'description': 'Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.', 'detailedDescription': 'The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are at least 17 years of age and has full legal capacity to volunteer.\n2. Have understood and signed an information consent letter.\n3. Are willing and able to follow instructions and maintain the appointment schedule.\n4. Are an adapted soft toric contact lens wearer.\n5. Do not habitually wear either of the two study lens types.\n6. Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye.\n7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.\n8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses.\n\nExclusion Criteria:\n\n1. Are participating in any concurrent clinical or research study.\n2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use.\n3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable.\n4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.\n5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study.\n6. Have a history of not achieving comfortable CL use (5 days per week; \\> 8 hours/day)\n7. Are an employee of the Centre for Ocular Research \\& Education directly involved in the study (i.e. on the delegation log).'}, 'identificationModule': {'nctId': 'NCT06431061', 'briefTitle': 'Clinical Evaluation of Proclear Toric and Biofinity Toric', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Evaluation of Proclear Toric and Biofinity Toric', 'orgStudyIdInfo': {'id': 'EX-MKTG-158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens A (omafilcon B)', 'description': 'All participants will wear lens A for 15 minutes (Period 1).', 'interventionNames': ['Device: Lens A (omafilcon B)']}, {'type': 'EXPERIMENTAL', 'label': 'Lens B (comfilcon A)', 'description': 'All participants will wear lens B for 15 minutes (Period 2).', 'interventionNames': ['Device: Lens B (comfilcon A)']}], 'interventions': [{'name': 'Lens A (omafilcon B)', 'type': 'DEVICE', 'description': '15 minutes of daily wear.', 'armGroupLabels': ['Lens A (omafilcon B)']}, {'name': 'Lens B (comfilcon A)', 'type': 'DEVICE', 'description': '15 minutes of daily wear.', 'armGroupLabels': ['Lens B (comfilcon A)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Waterloo', 'country': 'Canada', 'facility': 'University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Lyndon Jones', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Ocular Research and Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centre for Ocular Research & Education, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}