Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 5:33 AM
Study NCT ID:
NCT01548833
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2012-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], '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': 'Jami Kern, PhD', '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 were collected for the duration of the trial.', 'eventGroups': [{'id': 'EG000', 'title': 'Dailies Total 1', 'description': 'Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TruEye', 'description': 'Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Clariti', 'description': 'Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dailies Total 1', 'description': 'Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.'}, {'id': 'OG001', 'title': 'TruEye', 'description': 'Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.'}, {'id': 'OG002', 'title': 'Clariti', 'description': 'Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.56', 'spread': '3.7759121', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '2.9676727', 'groupId': 'OG001'}, {'value': '11.86', 'spread': '3.5982819', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, 16 hours after lens insertion', 'description': 'The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall', 'description': 'All enrolled participants'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from one study center in the United Kingdom.', 'preAssignmentDetails': 'This reporting group includes all enrolled participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '3.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled participants'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-06', 'studyFirstSubmitDate': '2012-03-06', 'resultsFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-06', 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)', 'timeFrame': 'Day 7, 16 hours after lens insertion', 'description': 'The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myopia', 'Contact Lenses'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.\n* Require vision correction in both eyes.\n* Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.\n* Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.\n* Willing and able to wear study contact lenses 16 hours per day.\n* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.\n* Require monovision correction.\n* Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.\n* Ocular surgery/trauma within the last 6 months.\n* Topical or systemic antibiotic use within 7 days of enrollment.\n* Topical ocular or systemic corticosteroid use within 14 days of enrollment.\n* Pregnant and nursing women.\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': 'NCT01548833', 'briefTitle': 'Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses', 'orgStudyIdInfo': {'id': 'A00924'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dailies Total 1', 'description': 'Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.', 'interventionNames': ['Device: Delefilcon A contact lens', 'Device: Narafilcon A contact lens', 'Device: Filcon II 3 contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TruEye', 'description': 'Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.', 'interventionNames': ['Device: Delefilcon A contact lens', 'Device: Narafilcon A contact lens', 'Device: Filcon II 3 contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clariti', 'description': 'Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.', 'interventionNames': ['Device: Delefilcon A contact lens', 'Device: Narafilcon A contact lens', 'Device: Filcon II 3 contact lens']}], 'interventions': [{'name': 'Delefilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['DAILIES® TOTAL1™'], 'description': 'Silicone hydrogel contact lens for single use, daily disposable wear.', 'armGroupLabels': ['Clariti', 'Dailies Total 1', 'TruEye']}, {'name': 'Narafilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['1-DAY ACUVUE® TRUEYE™'], 'description': 'Silicone hydrogel contact lens for single use, daily disposable wear.', 'armGroupLabels': ['Clariti', 'Dailies Total 1', 'TruEye']}, {'name': 'Filcon II 3 contact lens', 'type': 'DEVICE', 'otherNames': ['Clariti™ 1-day'], 'description': 'Silicone hydrogel contact lens for single use, daily disposable wear', 'armGroupLabels': ['Clariti', 'Dailies Total 1', 'TruEye']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jami Kern, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}