Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT01629693
Status:
COMPLETED
Last Update Posted:
2014-11-06
First Post:
2012-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Jessie Lemp, GMA Affairs Lead', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from 10 Jul 2013 to 20 Nov 2013. AEs were obtained through volunteered and elicited comments from the participants.', 'description': 'An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. This analysis population includes all participants enrolled and exposed to test and control articles.', 'eventGroups': [{'id': 'EG000', 'title': 'Air Optix', 'description': 'Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis', 'otherNumAtRisk': 193, 'otherNumAffected': 0, 'seriousNumAtRisk': 193, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Biofinity', 'description': 'Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis', 'otherNumAtRisk': 188, 'otherNumAffected': 0, 'seriousNumAtRisk': 188, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Acanthamoeba keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Optix', 'description': 'Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis'}, {'id': 'OG001', 'title': 'Biofinity', 'description': 'Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Day 30', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30', 'description': "Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all participants who completed the protocol and had no major protocol violations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Air Optix', 'description': 'Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis'}, {'id': 'FG001', 'title': 'Biofinity', 'description': 'Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor comfort of study lenses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject decision unrelated to AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 22 sites located in the United States.', 'preAssignmentDetails': 'Of the 398 enrolled, 17 participants were exited as screen failures. This reporting group includes all participants who provided informed consent, were randomized, and utilized the study lenses (381).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Air Optix', 'description': 'Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis'}, {'id': 'BG001', 'title': 'Biofinity', 'description': 'Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '33.1', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '32.9', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized participants who utilized the study lenses.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-03', 'studyFirstSubmitDate': '2012-06-26', 'resultsFirstSubmitDate': '2014-11-03', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-03', 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30', 'timeFrame': 'Baseline, Day 30', 'description': "Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contact lenses', 'myopia', 'astigmatism'], 'conditions': ['Myopia', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must sign written informed consent document.\n* Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT \\& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).\n* Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.\n* Current contact lens prescription within the available parameters of both study products.\n* Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.\n* Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period.\n* Willing and able to follow instructions, study procedures and maintain the appointment schedule.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT \\& DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.\n* Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.\n* Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.\n* A history of ocular surgery/trauma within the last 6 months.\n* Topical or systemic antibiotics use within 7 days of enrollment.\n* Topical ocular or systemic corticosteroids use within 14 days of enrollment.\n* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01629693', 'briefTitle': 'Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses', 'orgStudyIdInfo': {'id': 'A00973'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Air Optix', 'description': 'Lotrafilcon B contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).', 'interventionNames': ['Device: Lotrafilcon B contact lenses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biofinity', 'description': 'Comfilcon A contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).', 'interventionNames': ['Device: Comfilcon A contact lenses']}], 'interventions': [{'name': 'Lotrafilcon B contact lenses', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® AQUA', 'AIR OPTIX® for ASTIGMATISM'], 'description': "Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription", 'armGroupLabels': ['Air Optix']}, {'name': 'Comfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['Biofinity® Sphere', 'Biofinity® Toric'], 'description': "Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription", 'armGroupLabels': ['Biofinity']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jami Kern, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}