Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-05 @ 4:09 AM
Study NCT ID:
NCT06490302
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Two Toric Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega@coopervision.com', 'phone': '9256213761', 'title': 'Jose A. Vega,OD,MSc, PhD', 'organization': 'CooperVision, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of the study, approximately 4 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Lens A (Ocufilcon D)', 'description': 'All participants wore lens A for 15 minutes (Period 1).\n\nLens A (ocufilcon D): 15 minutes of daily wear', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lens B (Fanfilcon A)', 'description': 'All participants wore lens B for 15 minutes (Period 2).\n\nLens B (fanfilcon A): 15 minutes of daily wear', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens A (Ocufilcon D)', 'description': 'All participants wore lens A for 15 minutes (Period 1).\n\nLens A (ocufilcon D): 15 minutes of daily wear'}, {'id': 'OG001', 'title': 'Lens B (Fanfilcon A)', 'description': 'All participants wore lens B for 15 minutes (Period 2).\n\nLens B (fanfilcon A): 15 minutes of daily wear'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 15 minutes of daily wear', 'description': 'Overall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 4= Perfect)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lens A (Ocufilcon D)', 'description': 'All participants wore lens A for 15 minutes (Period 1).\n\nLens A (ocufilcon D): 15 minutes of daily wear'}, {'id': 'FG001', 'title': 'Lens B (Fanfilcon A)', 'description': 'All participants wore lens B for 15 minutes (Period 2).\n\nLens B (fanfilcon A): 15 minutes of daily wear'}], 'periods': [{'title': 'Period 1: Lens A (15 Minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'comment': 'All participants received Lens A in Period 1.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'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': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Forty participants were screened. All the participants who were eligible in the study were included in the analysis. (n=40)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Includes all Study Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.6', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', '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': '2024-02-06', 'size': 1285482, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-04T10:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2024-06-28', 'resultsFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-04', 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Fit Acceptance', 'timeFrame': 'At the end of 15 minutes of daily wear', 'description': 'Overall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 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 this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is between 18 and 40 years of age (inclusive)\n* Has had a self-reported visual exam in the last two years.\n* Is an adapted soft contact lens wearer.\n* Is not a habitual wearer of either study lens.\n* Has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.\n* Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25D in both eyes.\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 informed consent letter.\n* Patient contact lens refraction should fit within the available parameters of the study lenses.\n* Is willing to comply with the wear schedule (at least 5 days per week, \\>8 hours/day assuming there are no contraindications for doing so).\n* Is willing to comply with the visit schedule.\n\nExclusion Criteria:\n\n* Has a CL prescription outside the range of the available parameters of the study lenses.\n* Has a spectacle cylinder less than -0.75D or more than -2.50D of cylinder in either eye.\n* Slit lamp findings that would contraindicate contact lens wear such as:\n\n 1. Pathological dry eye or associated findings\n 2. Pterygium, pinguecula, or corneal scars within the visual axis\n 3. Neovascularization \\> 0.75 mm in form of the limbus\n 4. Giant papillary conjuctivitis (GCP) worse than grade 1\n 5. Anterior uveitis or iritis (past or present)\n 6. Seborrheic eczema, seborrheic conjunctivitis\n 7. History of corneal ulcers or fungal infections\n 8. Poor personal hygiene\n 9. Has a known history of corneal hypoesthesia (reduced corneal sensitivity)\n 10. Has aphakia, keratoconus or a highly irregular cornea.\n 11. Has Presbyopia or has dependence on spectacles for near work over the contact lenses.\n 12. Has undergone corneal refractive surgery.\n 13. Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT06490302', 'briefTitle': 'Clinical Evaluation of Two Toric Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Evaluation of Biomedics Monthly Toric and Avaira Vitality Toric', 'orgStudyIdInfo': {'id': 'EX-MKTG-157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens A (ocufilcon D)', 'description': 'All participants will wear lens A for 15 minutes (Period 1).', 'interventionNames': ['Device: Lens A (ocufilcon D)']}, {'type': 'EXPERIMENTAL', 'label': 'Lens B (fanfilcon A)', 'description': 'All participants will wear lens B for 15 minutes (Period 2).', 'interventionNames': ['Device: Lens B (fanfilcon A)']}], 'interventions': [{'name': 'Lens A (ocufilcon D)', 'type': 'DEVICE', 'description': '15 minutes of daily wear', 'armGroupLabels': ['Lens A (ocufilcon D)']}, {'name': 'Lens B (fanfilcon A)', 'type': 'DEVICE', 'description': '15 minutes of daily wear', 'armGroupLabels': ['Lens B (fanfilcon A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06760', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Consultorio Optométrico Queretaro', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Ruben Guerrero, MSc, FIACLE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Autonomous University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}