Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-01 @ 10:02 PM
Study NCT ID:
NCT07444658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of Two Daily Disposable Multifocal Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Visual Acuity', 'timeFrame': 'Through study completion, approximately 4 hours', 'description': 'High contrast high luminance (HCHL) distance binocular visual acuity (logMAR)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'This study will compare the performance of two daily disposable multifocal soft contact lenses.', 'detailedDescription': 'This is a double-masked, randomized, crossover, 1-week, real world dispensing study, where participants will wear two designs of daily disposable soft multifocal contact lenses for 5-7 days each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. They are at least 18 years of age.\n2. They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent.\n3. They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction,) and have worn lenses at least 3 days a week for at least the past six months.\n4. They have a minimum reading add of +0.75DS (based on their spectacle refraction)\n5. They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and refractive astigmatism of no greater than -0.75DC in each eye.\n6. They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye.\n\nExclusion Criteria:\n\n1. They have an ocular disorder which would normally contra-indicate contact lens wear.\n2. They have a systemic disorder which would normally contra-indicate contact lens wear.\n3. They are aphakic.\n4. They have had corneal refractive surgery.\n5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.'}, 'identificationModule': {'nctId': 'NCT07444658', 'briefTitle': 'Performance of Two Daily Disposable Multifocal Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Performance of Two Daily Disposable Multifocal Contact Lenses', 'orgStudyIdInfo': {'id': 'MKTG-26-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens A then Lens B', 'description': 'Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week.', 'interventionNames': ['Device: Lens A (kalfilcon A)']}, {'type': 'EXPERIMENTAL', 'label': 'Lens B then Lens A', 'description': 'Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week.', 'interventionNames': ['Device: Lens B (stenfilcon A)']}], 'interventions': [{'name': 'Lens A (kalfilcon A)', 'type': 'DEVICE', 'description': 'Daily disposable, soft contact lenses worn for one week', 'armGroupLabels': ['Lens A then Lens B']}, {'name': 'Lens B (stenfilcon A)', 'type': 'DEVICE', 'description': 'Daily disposable, soft contact lenses worn for one week', 'armGroupLabels': ['Lens B then Lens A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94720', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Berkeley', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'centralContacts': [{'name': 'Jose A Vega, OD,MSc,PhD', 'role': 'CONTACT', 'email': 'jvega2@coopervision.com', 'phone': '9256213761'}], 'overallOfficials': [{'name': 'Meng C Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Berkeley'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision International Limited (CVIL)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, Berkeley', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}