Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05308069
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2022-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contact Lens Optics and Visual Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-19', 'mcpReleaseN': 3, 'releaseDate': '2023-11-28'}, {'resetDate': '2024-02-05', 'mcpReleaseN': 4, 'releaseDate': '2024-02-02'}], 'estimatedResultsFirstSubmitDate': '2023-11-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-06', 'studyFirstSubmitDate': '2022-03-24', 'studyFirstSubmitQcDate': '2022-03-24', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual performance', 'timeFrame': 'Through completion of study visit, an average of 3 hours', 'description': 'Low contrast visual performance will be measured at different pupil sizes for each subject while wearing each of the two lenses'}], 'secondaryOutcomes': [{'measure': 'Refractive error', 'timeFrame': 'Through completion of study visit, an average of 3 hours', 'description': 'Refractive error will be measured with an autorefractor and an aberrometer with subjects wearing each of the two lenses'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'This study will evaluate changes in visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read and understand the informed consent document\n* 18 to 39 years of age (inclusive)\n* Best corrected visual acuity of 20/25 or better in the right eye\n* Refractive error from -1.00D to -8.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)\n\nExclusion Criteria:\n\n* Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens\n* History of ocular trauma or surgery causing abnormal or distorted vision\n* Current Rigid Gas Permeable (RGP) contact lens wearers\n* Pregnant and/or lactating females, by self-report'}, 'identificationModule': {'nctId': 'NCT05308069', 'briefTitle': 'Contact Lens Optics and Visual Performance', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Contact Lens Optics and Visual Performance', 'orgStudyIdInfo': {'id': 'STUDY00003513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single vision contact lens', 'description': 'Subjects will wear a single vision soft contact lens during the study visit', 'interventionNames': ['Device: Single vision contact lens']}, {'type': 'OTHER', 'label': 'Multifocal contact lens', 'description': 'Subjects will wear a multifocal soft contact lens during the study visit', 'interventionNames': ['Device: Multifocal contact lens']}], 'interventions': [{'name': 'Single vision contact lens', 'type': 'DEVICE', 'otherNames': ['comfilcon A'], 'description': 'Subjects will wear a single vision soft contact lens only during the study visit', 'armGroupLabels': ['Single vision contact lens']}, {'name': 'Multifocal contact lens', 'type': 'DEVICE', 'otherNames': ['comfilcon A'], 'description': 'Subjects will wear a multifocal soft contact lens only during the study visit', 'armGroupLabels': ['Multifocal contact lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David A Berntsen, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston College of Optometry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David A Berntsen, OD PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David A Berntsen, OD PhD', 'investigatorAffiliation': 'University of Houston'}}}}