Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-04-25 @ 12:09 PM
Study NCT ID:
NCT02595502
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2015-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BPALL@its.jnj.com', 'phone': '904-443-1290', 'title': 'Brian Pall, O.D., M.S., F.A.A.O - Senrior Principal Research Optometrist', 'organization': 'Johnson & Johnson Vision Care Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the duration of the study. Approximately 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Delefilcon A', 'description': 'Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.', 'otherNumAtRisk': 285, 'otherNumAffected': 0, 'seriousNumAtRisk': 285, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Senofilcon A', 'description': 'Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.', 'otherNumAtRisk': 285, 'otherNumAffected': 0, 'seriousNumAtRisk': 285, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}, {'units': 'Number of Observations', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.07', 'spread': '27.752', 'groupId': 'OG000'}, {'value': '71.87', 'spread': '26.494', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Week', 'description': 'Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Observations', 'denomUnitsSelected': 'Number of Observations', 'populationDescription': 'The analysis population consists of subjects that completed the study without a major protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delefilcon A /Senofilcon A/Delefilcon A', 'description': 'Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third.'}, {'id': 'FG001', 'title': 'Senofilcon A/Delefilcon A/Senofilcon A', 'description': 'Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Received incorrect lens at Period 1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received Incorrect Treatment at period 3', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 286 subjects were enrolled in this study. Of the enrolled subjects 1 subject did meet the eligibility criteria and 285 subjects were randomized. Of the randomized subjects 9 were discontinued and 276 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dispensed Subjects', 'description': 'All subjects that were dispensed at least one study lens throughout the duration of the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '6.13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '198', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects that were dispensed at least one study lens.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2015-11-02', 'resultsFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-10', 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Comfort', 'timeFrame': '1 Week', 'description': 'Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vision Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.\n* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.\n* The subject must be between (and including) 18 and 39 years of age.\n* The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.\n* The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye.\n* The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.\n* The subject must have best corrected visual acuity of 20/25 or better in each eye.\n\nExclusion Criteria:\n\n* Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).\n* Any ocular or systemic allergies or diseases that may interfere with contact lens wear.\n* Any autoimmune disease or use of medication, which may interfere with contact lens wear.\n* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.\n* Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).\n* Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.\n* Any ocular infection.\n* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n* Monovision, multi-focal, toric, or extended wear contact lens correction.\n* Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.\n* History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.\n* Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.'}, 'identificationModule': {'nctId': 'NCT02595502', 'briefTitle': 'Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-5743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 1: Test Control Test', 'description': 'Test/control/test using the Johnson \\& Johnson Vision Care (JJVC) Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each in between lenses for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn.', 'interventionNames': ['Device: JJVC Marketed Contact Lens (Test)', 'Device: Competitor Marketed Contact Lens (Control)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 2: Control Test Control', 'description': 'Control/test/control using the JJVC Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn.', 'interventionNames': ['Device: JJVC Marketed Contact Lens (Test)', 'Device: Competitor Marketed Contact Lens (Control)']}], 'interventions': [{'name': 'JJVC Marketed Contact Lens (Test)', 'type': 'DEVICE', 'otherNames': ['senofilcon A'], 'armGroupLabels': ['Sequence 1: Test Control Test', 'Sequence 2: Control Test Control']}, {'name': 'Competitor Marketed Contact Lens (Control)', 'type': 'DEVICE', 'otherNames': ['delefilcon A'], 'armGroupLabels': ['Sequence 1: Test Control Test', 'Sequence 2: Control Test Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Becky Bizzle, OD', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '32259', 'city': 'Fruit Cove', 'state': 'Florida', 'country': 'United States', 'facility': 'Complete Family Eye Care of Fruit Cove', 'geoPoint': {'lat': 30.11107, 'lon': -81.64176}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Golden Family Eyecare', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33625', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Lucy's Vision Center", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates of Winter Park', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'VisualEyes, Inc.', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '66757', 'city': 'Neodesha', 'state': 'Kansas', 'country': 'United States', 'facility': 'Advantage Eyecare Associates, LLC', 'geoPoint': {'lat': 37.41839, 'lon': -95.68026}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Sacco Eye Group', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '28037', 'city': 'Denver', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Advanced Family Eye Care', 'geoPoint': {'lat': 35.53125, 'lon': -81.0298}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'total Eye Care PA', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '17576', 'city': 'Jacksonville', 'state': 'Texas', 'country': 'United States', 'facility': 'Brian Frazier, OD', 'geoPoint': {'lat': 31.96378, 'lon': -95.2705}}, {'zip': '24153', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Timothy R. Poling, OD', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '53227', 'city': 'West Allis', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ziegler Leffingwell Eyecare', 'geoPoint': {'lat': 43.01668, 'lon': -88.00703}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}