Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 3:07 AM
Study NCT ID:
NCT02394756
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CColesb@ITS.JNJ.com', 'phone': '1 904 443 3449', 'title': 'Chantal Coles-Brennan- 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 4-weeks per subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Senofilcon A', 'description': 'Subjects wore the senofilcon A lens in any of the three periods during the study.', 'otherNumAtRisk': 42, 'otherNumAffected': 3, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lotrafilcon B', 'description': 'Subjects wore the lotrafilcon B lens in any of the three periods during the study.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Comfilcon A', 'description': 'Subjects wore the comfilcon A lens in any of the three periods during the study.', 'otherNumAtRisk': 42, 'otherNumAffected': 2, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Non-Significant Infiltrate Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders'}, {'term': 'Common Cold', 'notes': 'Not study related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Subjects wore the senofilcon A lens in any of the three periods during the study.'}, {'id': 'OG001', 'title': 'Lotrafilcon B', 'description': 'Subjects wore the lotrafilcon B lens in any of the three periods during the study.'}, {'id': 'OG002', 'title': 'Comfilcon A', 'description': 'Subjects wore the comfilcon A lens in any of the three periods during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'spread': '19.76', 'groupId': 'OG000'}, {'value': '53.6', 'spread': '23.34', 'groupId': 'OG001'}, {'value': '61.9', 'spread': '22.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-Day Follow-up', 'description': 'Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. Scores range 0-120.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that completed all study visits without a major protocol deviation.'}, {'type': 'PRIMARY', 'title': 'Subjective Overall Quality of Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A', 'description': 'Subjects wore the senofilcon A lens in any of the three periods during the study.'}, {'id': 'OG001', 'title': 'Lotrafilcon B', 'description': 'Subjects wore the lotrafilcon B lens in any of the three periods during the study.'}, {'id': 'OG002', 'title': 'Comfilcon A', 'description': 'Subjects wore the comfilcon A lens in any of the three periods during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '17.76', 'groupId': 'OG000'}, {'value': '63.8', 'spread': '18.24', 'groupId': 'OG001'}, {'value': '65.8', 'spread': '18.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-Day Follow-up', 'description': 'Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. Scores range 0-120.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that completed all study visits without a major protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Senofilcon A/Lotrafilcon B/Comfilcon A', 'description': 'Subjects randomized to this sequence wore the senofilcon A lens in the first period, the lotrafilcon B lens in the second period and the comfilcon A lens in the third period.'}, {'id': 'FG001', 'title': 'Senfilcon A/Comfilcon A/Lotrafilcon B', 'description': 'Subjects randomized to this sequence wore the senofilcon A lens in the first period, the comfilcon A lens in the second period and the lotrafilcon B lens in the third period.'}, {'id': 'FG002', 'title': 'Lotrafilcon B/Comfilcon A/Senofilcon A', 'description': 'Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the comfilcon A lens in the second period and the senofilcon A lens in the third period.'}, {'id': 'FG003', 'title': 'Lotrafilcon B/Senofilcon A/Comfilcon A', 'description': 'Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the senofilcon A lens in the second period and the comfilcon A lens in the third period.'}, {'id': 'FG004', 'title': 'Comfilcon A/Senofilcon A/ Lotrafilcon B', 'description': 'Subjects randomized to this sequence wore the comfilcon A lens in the first period, the senofilcon A lens in the second period and the lotrafilcon B lens in the third period.'}, {'id': 'FG005', 'title': 'Comfilcon A/Lotrafilcon B/Senofilcon A', 'description': 'Subjects randomized to this sequence wore the comfilcon A lens in the first period, the lotrafilcon B lens in the second period and the senofilcon A lens in the third period.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lens Discomfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Unsatisfactory Visual Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 52 subjects were enrolled in this study. Of the enrolled subjects 10 subjects did not meet the eligibility criteria and 42 subjects were dispensed study lenses. Of the dispensed subjects 37 completed the study while 5 subjects were discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dispensed Subjects', 'description': 'All subjects that were dispensed at least 1 study lens.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '4.74', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '42', '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2015-03-16', 'resultsFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-14', 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Overall Comfort', 'timeFrame': '1-Day Follow-up', 'description': 'Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. Scores range 0-120.'}, {'measure': 'Subjective Overall Quality of Vision', 'timeFrame': '1-Day Follow-up', 'description': 'Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. Scores range 0-120.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Visual Performance']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject must read, understand and sign the statement of Informed Consent and receive a fully executed copy of the form.\n2. The subject must be between 18 and 40 years of age.\n3. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -8.00D in each eye.\n4. The subject's refractive cylinder must be no more than -1.25 D cylindrical correction in each eye after vertexing to the corneal plane.\n5. The subject must have best corrected visual acuity of 0.20 or better in each eye.\n6. The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/ week and at least 8 hours/day during the month prior to enrollment.\n7. The subject must be using digital devices (any combination of computers, tablets, smartphones, etc.) for at least 8 hours over the course of a typical day.\n8. The subject should own a wearable pair of spectacles and wear them the day of the baseline visit.\n9. The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.\n10. The subject must meet normal eligibility conditions of binocular vision tests.\n11. The subject may not have any double vision at near with their habitual contact lens correction.\n\nExclusion Criteria:\n\n1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).\n2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion).\n3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).\n4. Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as subjects reporting headaches associated with birth control pills (at the investigator's discretion).\n5. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease.\n6. Any active ocular infection.\n7. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.\n8. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).\n9. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.\n10. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.\n11. Any known hypersensitivity or allergic reaction to the study products.\n12. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.\n13. History of binocular abnormality or strabismus.\n14. Employee of investigational clinic (e.g. Investigator, Coordinator, Technician)."}, 'identificationModule': {'nctId': 'NCT02394756', 'briefTitle': 'Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-5615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Marketed Soft Contact Lens (Test)', 'description': 'Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type.', 'interventionNames': ['Device: Marketed Soft Contact lens', 'Device: AIR OPTIX® AQUA', 'Device: Biofinity®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AIR OPTIX® AQUA', 'description': 'Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type.', 'interventionNames': ['Device: Marketed Soft Contact lens', 'Device: AIR OPTIX® AQUA', 'Device: Biofinity®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biofinity®', 'description': 'Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type.', 'interventionNames': ['Device: Marketed Soft Contact lens', 'Device: AIR OPTIX® AQUA', 'Device: Biofinity®']}], 'interventions': [{'name': 'Marketed Soft Contact lens', 'type': 'DEVICE', 'otherNames': ['senofilcon A'], 'description': 'Replacement schedule every 2 weeks', 'armGroupLabels': ['AIR OPTIX® AQUA', 'Biofinity®', 'Marketed Soft Contact Lens (Test)']}, {'name': 'AIR OPTIX® AQUA', 'type': 'DEVICE', 'otherNames': ['lotrafilcon B'], 'description': 'Replacement schedule every 4 weeks', 'armGroupLabels': ['AIR OPTIX® AQUA', 'Biofinity®', 'Marketed Soft Contact Lens (Test)']}, {'name': 'Biofinity®', 'type': 'DEVICE', 'otherNames': ['comfilcon A'], 'description': 'Replacement schedule every 4 weeks', 'armGroupLabels': ['AIR OPTIX® AQUA', 'Biofinity®', 'Marketed Soft Contact Lens (Test)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2I3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}