Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-26 @ 1:51 PM
Study NCT ID:
NCT03586167
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2018-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'CDMA Project Lead', 'organization': 'Alcon Research'}, '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': 'Dispense through study completion, an average of 1 month (30 days)', 'description': 'Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population included all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set), based on treatment-specific exposure.', 'eventGroups': [{'id': 'EG000', 'title': 'LID014341', 'description': 'LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Distance Visual Acuity (VA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LID014341', 'description': 'LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis'}, {'id': 'OG001', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Safety Analysis Set. Overall number of units analyzed is the number of eyes with non-missing response.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LID014341', 'description': 'LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis'}, {'id': 'FG001', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized and Treated', 'achievements': [{'groupId': 'FG000', 'numUnits': '116', 'numSubjects': '58'}, {'groupId': 'FG001', 'numUnits': '56', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '114', 'numSubjects': '57'}, {'groupId': 'FG001', 'numUnits': '56', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'Subjects were recruited from 4 study centers located in the US.', 'preAssignmentDetails': 'Of the 88 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (86).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LID014341', 'description': 'LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis'}, {'id': 'BG001', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '40.7', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '39.6', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'This analysis population included all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-18', 'size': 1148036, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-06T10:40', 'hasProtocol': True}, {'date': '2018-07-13', 'size': 954369, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-06T10:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2019-09-23', 'completionDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2018-07-02', 'dispFirstSubmitQcDate': '2019-09-23', 'resultsFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2018-07-02', 'dispFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-22', 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance Visual Acuity (VA)', 'timeFrame': 'Day 30', 'description': 'VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand and sign an informed consent form approved by an Institutional review board (IRB);\n* Successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;\n* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;\n* Willing to stop wearing habitual contact lenses for the duration of study participation.\n\nExclusion Criteria:\n\n* Any conditions or use of medications that could contraindicate contact lens wear;\n* History of or plan to have refractive surgery in either eye;\n* Irregular cornea in either eye;\n* Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;\n* Current or history of intolerance, hypersensitivity or allergy to any component of the study products;\n* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;\n* Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;\n* Habitual Biofinity contact lens wearers.'}, 'identificationModule': {'nctId': 'NCT03586167', 'briefTitle': 'Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens', 'orgStudyIdInfo': {'id': 'CLY935-C004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LID014341', 'description': 'LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis', 'interventionNames': ['Device: LID014341 contact lenses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biofinity', 'description': 'Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis', 'interventionNames': ['Device: Comfilcon A contact lenses']}], 'interventions': [{'name': 'LID014341 contact lenses', 'type': 'DEVICE', 'description': 'Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating', 'armGroupLabels': ['LID014341']}, {'name': 'Comfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['BIOFINITY©'], 'description': 'Silicone hydrogel contact lenses', 'armGroupLabels': ['Biofinity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '30097', 'city': 'Johns Creek', 'state': 'Georgia', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 34.02893, 'lon': -84.19858}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '38111', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Alcon Research', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}