Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01295905
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2011-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prospective Study of an Investigational Daily Disposable Contact Lens
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': {'phone': '1-800-241-7629', 'title': 'Director of Alcon Clinical, Atlanta', 'organization': 'Alcon Research'}, 'certainAgreement': {'otherDetails': "For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study: 19-JAN-2011 to 20-MAY-2011.', 'description': 'This reporting group includes all enrolled and exposed participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Delefilcon A', 'description': 'Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Narafilcon B', 'description': 'Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Sterile infiltrate with secondary iritis', 'notes': 'One eye. Resolved. Resumed wearing study lenses and completed the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}, {'id': 'OG001', 'title': 'Narafilcon B', 'description': 'Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months of wear, lenses replaced daily', 'description': 'Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per protocol.'}, {'type': 'SECONDARY', 'title': 'Overall Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}, {'id': 'OG001', 'title': 'Narafilcon B', 'description': 'Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months of wear, lenses replaced daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}, {'type': 'SECONDARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}, {'id': 'OG001', 'title': 'Narafilcon B', 'description': 'Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months of wear, lenses replaced daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}, {'type': 'SECONDARY', 'title': 'Overall Handling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delefilcon A', 'description': 'Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}, {'id': 'OG001', 'title': 'Narafilcon B', 'description': 'Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months of wear, lenses replaced daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delefilcon A', 'description': 'Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}, {'id': 'FG001', 'title': 'Narafilcon B', 'description': 'Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Met exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited and enrolled from six (6) US study centers.', 'preAssignmentDetails': 'This reporting group includes all enrolled participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Delefilcon A', 'description': 'Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}, {'id': 'BG001', 'title': 'Narafilcon B', 'description': 'Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.01', 'spread': '8.86', 'groupId': 'BG000'}, {'value': '31.39', 'spread': '10.05', 'groupId': 'BG001'}, {'value': '29.80', 'spread': '9.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2011-02-11', 'resultsFirstSubmitDate': '2012-04-18', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-18', 'studyFirstPostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity', 'timeFrame': '3 months of wear, lenses replaced daily', 'description': 'Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.'}], 'secondaryOutcomes': [{'measure': 'Overall Vision', 'timeFrame': '3 months of wear, lenses replaced daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Overall Comfort', 'timeFrame': '3 months of wear, lenses replaced daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Overall Handling', 'timeFrame': '3 months of wear, lenses replaced daily', 'description': 'As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.'}]}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with normal eyes who are not using any ocular medications.\n* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.\n* Willing and able to wear spherical contact lenses for at least 5 days per week.\n* Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.\n* Best spectacle-corrected visual acuity greater than or equal to 20/25.\n* Manifest cylinder less than or equal to 0.75D.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any active anterior segment ocular disease that would contraindicate contact lens wear.\n* Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.\n* History of refractive surgery or irregular cornea.\n* History of pathologically dry eye.\n* Eye injury within twelve weeks immediately prior to enrollment for this trial.\n* Currently enrolled in any clinical trial.\n* Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01295905', 'briefTitle': 'Prospective Study of an Investigational Daily Disposable Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'P-347-C-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'delefilcon A', 'description': 'Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.', 'interventionNames': ['Device: delefilcon A contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'narafilcon B', 'description': 'Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.', 'interventionNames': ['Device: narafilcon B contact lens']}], 'interventions': [{'name': 'delefilcon A contact lens', 'type': 'DEVICE', 'description': 'Investigational silicone hydrogel, single vision soft contact lens', 'armGroupLabels': ['delefilcon A']}, {'name': 'narafilcon B contact lens', 'type': 'DEVICE', 'description': 'Commercially marketed silicone hydrogel, single vision soft contact lens', 'armGroupLabels': ['narafilcon B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}