Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06170658
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2023-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
1 Week Crossover Dispensing Study Between Two Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'dispFirstSubmitDate': '2025-07-29', 'completionDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2023-12-06', 'dispFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High contrast, binocular, distance visual acuity', 'timeFrame': '7 days', 'description': 'Distance visual acuity (LogMAR) will be measured using high and low contrast computer-generated acuity charts.'}], 'secondaryOutcomes': [{'measure': 'Subjective Vision Quality', 'timeFrame': '7 days', 'description': 'Subjective vision quality on 0-100 scale, integer steps (0 = Very poor; 100 = Excellent vision, totally sharp)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.', 'detailedDescription': 'This is a prospective, bilateral, double masked (participant and investigator), randomized, cross-over dispensing study with 1 week wearing period in each arm by comparing visual acuity and subjective vision quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are 8 to 18 years of age inclusive and have full legal capacity to volunteer;\n2. Have read and signed and dated the Parental Permission Form (for those aged 16 and younger); participant has read, signed and dated the study Information Consent Letter (if aged 17 or 18 years) or Assent (aged 16 and younger);\n3. Are willing and able to follow instructions and maintain the appointment schedule;\n4. Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye;\n5. Currently wears spherical soft contact lenses or myopia control soft lenses;\n6. Have a pair of wearable back-up spectacles;\n7. Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;\n8. Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D\n9. Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction;\n10. Have clear corneas with no corneal scars or any active ocular disease;\n11. Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit.\n12. Demonstrate an acceptable fit with the study lenses.\n13. Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit;\n\nExclusion Criteria:\n\n1. Have taken part in another clinical research study within the last 14 days;\n2. Are currently habitual wearers of toric lenses.\n3. Have worn any rigid contact lenses or ortho-keratology lenses in the past 30 days\n4. Are an extended lens wearer (i.e., sleeping with their lenses)\n5. Are on ongoing atropine treatment for myopia control\n6. Have a difference of \\> 1.0 D in best vision sphere subjective refraction between eyes;\n7. Have amblyopia and/or strabismus/binocular vision problem\n8. Have any known active ocular disease, allergies and/or infection;\n9. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;\n10. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;\n11. Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study;\n12. Have undergone refractive error surgery or intraocular surgery;\n13. Are a member of CORE directly involved in the study.'}, 'identificationModule': {'nctId': 'NCT06170658', 'briefTitle': '1 Week Crossover Dispensing Study Between Two Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': '1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses', 'orgStudyIdInfo': {'id': 'CV-23-58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Lenses, Then Control Lenses', '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: Test Lenses (stenfilcon A)', 'Device: Control Lenses (omafilcon A)']}, {'type': 'EXPERIMENTAL', 'label': 'Control Lenses, Then Test Lenses', '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: Test Lenses (stenfilcon A)', 'Device: Control Lenses (omafilcon A)']}], 'interventions': [{'name': 'Test Lenses (stenfilcon A)', 'type': 'DEVICE', 'description': 'Daily disposable, silicone hydrogel investigational lenses for one week', 'armGroupLabels': ['Control Lenses, Then Test Lenses', 'Test Lenses, Then Control Lenses']}, {'name': 'Control Lenses (omafilcon A)', 'type': 'DEVICE', 'description': 'Daily disposable, hydrogel commercially available lenses for one week', 'armGroupLabels': ['Control Lenses, Then Test Lenses', 'Test Lenses, Then Control Lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD,FCOptom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}