Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT01819194
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2013-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Contact Lens Comfort Relative to Meibomian Gland Status
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RA-VISUS-ClnclStds@its.jnj.com', 'phone': '904-443-1391', 'title': 'Daria Wicks', 'organization': 'Vistakon'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data was collected over the course of the study, approximately 1 week.', 'eventGroups': [{'id': 'EG000', 'title': 'Senofilcon A, 38% Water', 'description': 'Senofilcon A, 38% water', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A, 38% Water', 'description': 'Senofilcon A, 38% water'}], 'classes': [{'categories': [{'measurements': [{'value': '58.67', 'spread': '18.430', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post 3 days of wear', 'description': 'CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects are those who were enrolled, randomized, and completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A, 38% Water', 'description': 'Senofilcon A, 38% water'}], 'classes': [{'title': 'Grade 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post 3 days of wear', 'description': 'Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall', 'description': 'Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Loss of study articles', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'A total of 64 subjects were enrolled in this study. Of the enrolled subjects 2 did not meet the eligibility criteria and 62 were dispensed a study lens. Of the dispensed subjects 60 completed the study and 2 were discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dispensed Subjects', 'description': 'All subjects that were dispensed the study lens.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.53', 'spread': '3.050', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '64 subjects enrolled with 60 Completing'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2013-03-24', 'resultsFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2013-03-26', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-02', 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)', 'timeFrame': 'Post 3 days of wear', 'description': 'CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.'}, {'measure': 'Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale', 'timeFrame': 'Post 3 days of wear', 'description': 'Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Meibomian Gland Dysfunction']}, 'descriptionModule': {'briefSummary': 'This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject must be able to read, understand, and sign the statement of informed consent and receive a fully executed copy of the form.\n2. The subject be able and willing to adhere to the instructions set forth in this clinical protocol.\n3. The subject must be 18 and less than 39 years of age.\n4. The subject must be an adapted soft contact lens wearer in both eyes (Defined as having been a full times lens wearer for at least 3 months).\n5. Subjects must be current full time daily wearers of Acuvue Oasys lenses (defined as, at least 6 hours per day, 5 days per week).\n6. The subject's spherical equivalent distance refraction must be in the range of 0.00 to -6.00D in each eye.\n7. The subject must present at visit 1 with a current copy of their spectacle prescription.\n8. The subject must have the best corrected visual acuity of 0.18 or better in each eye as assessed by LogMAR chart.\n9. The subject must have normal eyes (i.e., no ocular medication, or infections of any type)\n\nExclusion Criteria:\n\n1. Wear Acuvue Oasys with Hydraclear Plus on an extended wear basis.\n2. Wear Acuvue Oasys with Hydraclear Plus for astigmatism.\n3. History of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.\n4. Use of concomitant ocular medications during the study period. Topical artificial tears or contact lens lubricants are allowed, but no instillation on the day of examinations.\n5. Any systemic disease, autoimmune disease, or use of medications, which may interfere with contact lens wear.\n6. Subjects using medications influencing tear production such as steroids, immunosuppressive agents and/or anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in this study if they have not been on a stable dosing regimen for 30 days prior to the Eligibility Visit. Subjects may use birth control medications since there is inconclusive evidence relative to the influence on tear film.\n7. Any infectious disease (e.g. Hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV, by self report).\n8. Subjects reporting discomfort at screening visit related to fit or care system abnormalities (both determined by the investigator), ocular conditions such as conjunctival infections, iritis.\n9. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).\n10. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.\n11. Entropion, ectropion, extrusion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion,aphakia, or moderate or above corneal distortion by keratometry.\n12. Any previous, or planned, ocular or intraocular surgery (radial keratotomy, LASIK, ETC.)\n13. 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.\n14. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.\n15. Monovision or multi-focal contact lens correction\n16. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment\n17. History of binocular vision abnormality or strabismus\n18. History of serious mental illness\n19. History of seizures"}, 'identificationModule': {'nctId': 'NCT01819194', 'briefTitle': 'Contact Lens Comfort Relative to Meibomian Gland Status', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-5282'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'senofilcon A', 'description': 'Acuvvue Oasys with Hydaclear Plus with 38% water.', 'interventionNames': ['Device: senofilcon A']}], 'interventions': [{'name': 'senofilcon A', 'type': 'DEVICE', 'armGroupLabels': ['senofilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}