Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-29 @ 4:01 PM
Study NCT ID:
NCT01951703
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Senofilcon A Investigational Manufacturing Process
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jaraujo7@jnj.com', 'phone': '904 443-1379', 'title': 'Jurandir Araujo', 'organization': 'Clinical Compliance Manager'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control, Senofilcon A', 'description': 'Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.', 'otherNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test, Senofilcon A', 'description': 'Subjects who received Test lens senofilcon A in either the first two weeks or the last two weeks of the study,', 'otherNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Overall Comfort (Using CLUE )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control, Senofilcon A', 'description': 'Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.'}, {'id': 'OG001', 'title': 'Test, Senofilcon A', 'description': 'Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '24.85', 'groupId': 'OG000'}, {'value': '65.0', 'spread': '26.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Contact Lens User Experience Comfort scores (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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes'}, {'type': 'PRIMARY', 'title': 'Subjective Overall Vision (Using CLUE )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control, Senofilcon A', 'description': 'Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.'}, {'id': 'OG001', 'title': 'Test, Senofilcon A', 'description': 'Subjects who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '20.75', 'groupId': 'OG000'}, {'value': '65.2', 'spread': '20.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Contact Lens User Experience Vision scores (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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control/Test', 'description': 'Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study.'}, {'id': 'FG001', 'title': 'Test/Control', 'description': 'Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject was not compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory Lens fitting', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 136 subjects were enrolled in the study; 9 subjects did not meet the inclusion and exclusion criteria and not randomized. Of the 127 randomized subjects, 6 were prematurely discontinued from the study and 2 were excluded from the analysis due to major protocol deviations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control/Test', 'description': 'Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study.'}, {'id': 'BG001', 'title': 'Test/Control', 'description': 'Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '9.73', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '9.63', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '9.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This includes all randomized subjects'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2013-09-23', 'resultsFirstSubmitDate': '2015-07-06', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-06', 'studyFirstPostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Overall Comfort (Using CLUE )', 'timeFrame': '2 weeks', 'description': 'Contact Lens User Experience Comfort scores (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.'}, {'measure': 'Subjective Overall Vision (Using CLUE )', 'timeFrame': '2 weeks', 'description': 'Contact Lens User Experience Vision scores (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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Visual Acuity', 'Comfort', 'Overall Vision']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of a new contact lens hydration process', 'detailedDescription': 'To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, '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 at least 18 and not more than 70 years of age.\n* The subject's refractive cylinder must be \\< 0.75D in each eye.\n* The subject must have best corrected visual acuity of 20/25 or better in each eye.\n* The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses.\n* The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.\n* The subject must have normal eyes (i.e., no ocular medications or infections of any type).\n* The subject's required spherical contact lens prescription must be in the range of -0.50 to -9.00D in each eye.\n\nExclusion Criteria:\n\n* Currently pregnant or lactating (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 systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear.\n* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.\n* Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, 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 known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.\n* Any ocular infection.\n* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n* Monovision or multi-focal 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.\n* Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).\n* Suspicion of or recent history of alcohol or substance abuse.\n* History of serious mental illness.\n* History of seizures.\n* Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)"}, 'identificationModule': {'nctId': 'NCT01951703', 'briefTitle': 'Senofilcon A Investigational Manufacturing Process', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process', 'orgStudyIdInfo': {'id': 'CR-5509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control, senofilcon A', 'description': 'Subjects received Control lens, senofilcon A during the first two weeks of the study then Test lens, senofilcon A in the last two weeks of the study.', 'interventionNames': ['Device: senofilcon A']}, {'type': 'EXPERIMENTAL', 'label': 'Test, senofilcon A', 'description': 'Subjects received Test lens, senofilcon A during the first two weeks of the study then Control lens, senofilcon A in the last two weeks of the study.', 'interventionNames': ['Device: senofilcon A']}], 'interventions': [{'name': 'senofilcon A', 'type': 'DEVICE', 'description': 'Control, senfilcon A', 'armGroupLabels': ['Control, senofilcon A']}, {'name': 'senofilcon A', 'type': 'DEVICE', 'description': 'Test, senofilcon A', 'armGroupLabels': ['Test, senofilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}], 'overallOfficials': [{'name': 'Brian Pall, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Vision Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}