Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT01695369
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2012-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Comfilcon A and Senofilcon A Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbergmanson@uh.edu', 'phone': '713-743-1950', 'title': 'Jan Bergmanson, OD,PhD', 'organization': 'University of Houston, College of Optometry, TERTC'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Overall Study Participants', 'description': 'Senofilcon A and Comfilcon A', 'otherNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comfilcon A', 'description': 'Comfilcon A / CooperVision Biofinity Sphere', 'otherNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Responses for Comfort Rated on a 0-100 Visual Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A', 'description': 'comfilcon A (CooperVision Biofinity®Sphere)'}, {'id': 'OG001', 'title': 'Senofilcon A', 'description': 'Senofilcon A (Vistakon Acuvue® Oasys)'}], 'classes': [{'title': 'Baseline Insertion', 'categories': [{'measurements': [{'value': '86', 'spread': '15', 'groupId': 'OG000'}, {'value': '87', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': '10 Minutes', 'categories': [{'measurements': [{'value': '89', 'spread': '14', 'groupId': 'OG000'}, {'value': '91', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': '5 Hours', 'categories': [{'measurements': [{'value': '83', 'spread': '19', 'groupId': 'OG000'}, {'value': '84', 'spread': '18', 'groupId': 'OG001'}]}]}, {'title': '10 Hours', 'categories': [{'measurements': [{'value': '79', 'spread': '23', 'groupId': 'OG000'}, {'value': '81', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Insertion, 10 Minutes, 5 hours and 10 hours', 'description': 'Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study Participants', 'description': 'Senofilcon A and Comfilcon A'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye. The subject is expected to attend the baseline visit not wearing their habitual contact lens products for at least 12 hours.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Participants', 'description': 'Senofilcon A and Comfilcon A'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'eyes'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2012-09-26', 'resultsFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-03', 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Responses for Comfort Rated on a 0-100 Visual Scale.', 'timeFrame': 'Baseline Insertion, 10 Minutes, 5 hours and 10 hours', 'description': 'Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Evaluation of Comfilcon A and Senofilcon A Lenses', 'detailedDescription': 'Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must satisfy the following conditions prior to inclusion in the study:\n\n* Has had an oculo-visual examination in the last two years\n* Is at least 18 years of age and has full legal capacity to volunteer\n* Has read and understood the information consent letter\n* Is willing and able to follow instructions and maintain the appointment schedule\n* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction\n* Currently wears soft contact lenses at least 3 days a week, 8 hours a day\n* Has clear corneas and no active ocular disease\n* Has not worn lenses for at least 12 hours before the examination\n* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:\n\n * No amblyopia\n * No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)\n * No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).\n * No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \\[infiltrates\\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)\n * No aphakia\n * Has prescription to match the available power range.\n\nExclusion Criteria:\n\nAny of the following will render a subject ineligible for inclusion:\n\n* Greater than 0.75 of refractive astigmatism in either eye\n* Has never worn contact lenses before\n* Wears contact lenses on an extended wear basis\n* Has any systemic disease affecting ocular health\n* Is a known sufferer of ocular allergies\n* Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants\n* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities\n* Is aphakic\n* Has undergone corneal refractive surgery.\n* Is wearing monovision\n* Is participating in any other type of clinical or research study\n* Female who is currently pregnant or is breast-feeding\n* Has \\> grade 1 ocular corneal staining in both type and extent by \\> grade 2 in either type or extent'}, 'identificationModule': {'nctId': 'NCT01695369', 'briefTitle': 'Evaluation of Comfilcon A and Senofilcon A Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses', 'orgStudyIdInfo': {'id': 'CV-12-54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Senofilcon A', 'description': 'Senofilcon A; Comfilcon A', 'interventionNames': ['Device: Senofilcon A; Comfilcon A', 'Device: Comfilcon A; Senofilcon A']}, {'type': 'EXPERIMENTAL', 'label': 'Comfilcon A', 'description': 'Comfilcon A; Senofilcon A', 'interventionNames': ['Device: Senofilcon A; Comfilcon A', 'Device: Comfilcon A; Senofilcon A']}], 'interventions': [{'name': 'Senofilcon A; Comfilcon A', 'type': 'DEVICE', 'description': 'Senofilcon A; Comfilcon A', 'armGroupLabels': ['Comfilcon A', 'Senofilcon A']}, {'name': 'Comfilcon A; Senofilcon A', 'type': 'DEVICE', 'description': 'Comfilcon A; Senofilcon A', 'armGroupLabels': ['Comfilcon A', 'Senofilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston College of Optometry, TERTC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jan Bergmanson, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston College of Optometry, TERTC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}