Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT06462456
Status:
TERMINATED
Last Update Posted:
2025-07-20
First Post:
2024-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Management decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance Visual Acuity with Study Lenses at Baseline', 'timeFrame': 'Baseline', 'description': "Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place."}, {'measure': 'Distance Visual Acuity with Study Lenses at Year 1 Follow-Up', 'timeFrame': 'Year 1', 'description': "Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place."}, {'measure': 'Incidence of Corneal Infiltrative Events', 'timeFrame': 'Up to Year 1', 'description': 'A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.'}, {'measure': 'Incidence of Microbial Keratitis', 'timeFrame': 'Up to Year 1', 'description': 'Microbial keratitis is a sight-threatening infection of the cornea.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Myopia', 'Hyperopia', 'Astigmatism'], 'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.', 'detailedDescription': 'This study consists of a Baseline Visit and a Year 1 Visit.\n\nThe Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a PRECISION1™ sphere or toric contact lens prescription was released. The Baseline Visit will be retrospective, with all assessments obtained from chart review.\n\nThe Year 1 Visit is defined as the visit that occurs 1 year (-2/+4 months) since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit. The Year 1 Visit may be prospective or retrospective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from clinical sites located in the United States.', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Subject (or subject's legal representative) is able to understand and sign an informed consent/assent form approved by an Institutional Review Board (IRB), unless appropriate consent waiver for the retrospective chart review is provided by the IRB.\n* Verofilcon A (sphere or toric) contact lens wear as described in the protocol.\n* Best corrected spectacle distance visual acuity (VA) 20/25 or better at baseline.\n* Healthy, non-diseased eyes, as determined/known by the Investigator.\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Any ocular disease or condition that would contraindicate contact lens wear present at baseline.\n* Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.\n* Other protocol-defined exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT06462456', 'briefTitle': 'Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical Soft Contact Lenses (Verofilcon A) and PRECISION1T™ for Astigmatism Contact Lenses (Verofilcon A)', 'orgStudyIdInfo': {'id': 'CLE383-I001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRECISION1 Sphere', 'description': 'Verofilcon A spherical soft contact lenses worn in both eyes in a real-world setting', 'interventionNames': ['Device: Verofilcon A spherical soft contact lenses']}, {'label': 'PRECISION1 Toric', 'description': 'Verofilcon A toric soft contact lenses worn in both eyes in a real-world setting', 'interventionNames': ['Device: Verofilcon A toric soft contact lenses']}], 'interventions': [{'name': 'Verofilcon A spherical soft contact lenses', 'type': 'DEVICE', 'otherNames': ['PRECISION1™'], 'description': 'Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia)', 'armGroupLabels': ['PRECISION1 Sphere']}, {'name': 'Verofilcon A toric soft contact lenses', 'type': 'DEVICE', 'otherNames': ['PRECISION1™ for Astigmatism'], 'description': 'Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with astigmatism', 'armGroupLabels': ['PRECISION1 Toric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92131', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Optometric Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32246', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pearle Vision', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Vision Health Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60406', 'city': 'Blue Island', 'state': 'Illinois', 'country': 'United States', 'facility': 'Vision Salon Eye Care Associates', 'geoPoint': {'lat': 41.65726, 'lon': -87.68005}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois College of Optometry', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'CORL, Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '55344', 'city': 'Eden Prairie', 'state': 'Minnesota', 'country': 'United States', 'facility': 'The Eye Doctors Inc', 'geoPoint': {'lat': 44.85469, 'lon': -93.47079}}, {'zip': '55436', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Cornea and Contact Lens Institute of Minnesota', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55340', 'city': 'Medina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Complete Eye Care of Medina', 'geoPoint': {'lat': 45.03524, 'lon': -93.58246}}, {'zip': '14701', 'city': 'Jamestown', 'state': 'New York', 'country': 'United States', 'facility': 'Spectrum Eyecare', 'geoPoint': {'lat': 42.097, 'lon': -79.23533}}, {'zip': '43065', 'city': 'Powell', 'state': 'Ohio', 'country': 'United States', 'facility': 'Eyecare Professionals, Inc', 'geoPoint': {'lat': 40.15784, 'lon': -83.07519}}, {'zip': '38111', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Optometry Group, PLLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Clinical Trial Lead, VC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}