Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT05976750
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Air Optix® Night and Day® Aqua Daily Wear
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'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-07-26', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance visual acuity by eye', 'timeFrame': 'Year 1', 'description': "The subject's chart will be reviewed for distance visual acuity."}, {'measure': 'Incidence of corneal infiltrative events', 'timeFrame': 'Up to Year 1', 'description': "The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam."}, {'measure': 'Incidence of microbial keratitis', 'timeFrame': 'Up to Year 1', 'description': "The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Refractive Errors', 'Myopia', 'Hyperopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.', 'detailedDescription': 'This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.\n\nThe anticipated duration of the study is approximately 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators will enroll charts following a pre-identified process.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal eyes, as determined by the Investigator\n* At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality\n* Baseline and 1-year visit charts available\n* Other protocol-specified inclusion criteria may apply\n\nExclusion Criteria\n\n* Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline\n* Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline\n* History of refractive surgery or irregular cornea\n* Other protocol-specified exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT05976750', 'briefTitle': 'Air Optix® Night and Day® Aqua Daily Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Air Optix® Night and Day® Aqua Daily Wear', 'orgStudyIdInfo': {'id': 'CLD265-N002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AONDA contact lenses', 'description': 'Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional', 'interventionNames': ['Device: Lotrafilcon A contact lenses']}, {'label': 'PV2 contact lenses', 'description': 'Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional', 'interventionNames': ['Device: Balafilcon A contact lenses']}], 'interventions': [{'name': 'Lotrafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['AONDA', 'Air Optix® Night and Day® Aqua'], 'description': 'CE-marked silicone hydrogel contact lenses for daily wear use', 'armGroupLabels': ['AONDA contact lenses']}, {'name': 'Balafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['PV2', 'PureVision® 2'], 'description': 'CE-marked silicone hydrogel contact lenses for daily wear use', 'armGroupLabels': ['PV2 contact lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Clinical Trial Lead, CRD Vision Care', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}