Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT03567005
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2018-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Validation of DACP Digital Design
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 14 days', 'description': 'Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects/eyes that were exposed to any study lenses in the study (Safety Analysis Set), based on treatment-specific exposure.', 'eventGroups': [{'id': 'EG000', 'title': 'DACP Digital', 'description': 'All subjects exposed to nelfilcon A digital contact lenses', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DACP', 'description': 'All subjects exposed to nelfilcon A contact lenses', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Distance Visual Acuity (VA) (logMAR, OU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DACP Digital', 'description': 'Nelfilcon A digital contact lenses worn bilaterally for 7 days in a daily disposable modality.'}, {'id': 'OG001', 'title': 'DACP', 'description': 'Nelfilcon A contact lenses worn bilaterally for 7 days in a daily disposable modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean (LSM) Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.008', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The pre-specified non-inferiority margin is 0.05. With a sample size of 36 (18 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in distance visual acuity with assumed standard deviation of 0.098 for paired difference (one-sided alpha=0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, each product', 'description': 'VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set with non-missing response'}, {'type': 'SECONDARY', 'title': 'Overall Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DACP Digital', 'description': 'Nelfilcon A digital contact lenses worn bilaterally for 7 days in a daily disposable modality.'}, {'id': 'OG001', 'title': 'DACP', 'description': 'Nelfilcon A contact lenses worn bilaterally for 7 days in a daily disposable modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The pre-specified non-inferiority margin is 1.0. With a sample size of 48 (24 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in subjective overall vision with assumed standard deviation of 2.29 for paired differences (one-sided alpha=0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, each product', 'description': 'Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set with non-missing response'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DACP Digital Then DACP', 'description': 'Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.'}, {'id': 'FG001', 'title': 'DACP Then DACP Digital', 'description': 'Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.'}], 'periods': [{'title': 'Period 1, First 7 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2, Second 7 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 5 investigative sites located in the United States.', 'preAssignmentDetails': 'All 60 enrolled subjects were randomized and exposed to the investigational products.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Nelfilcon A digital contact lenses and nelfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '5.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized subjects who were exposed to any study lenses evaluated in this study (Full Analysis Set).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-16', 'size': 1212614, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-22T12:20', 'hasProtocol': True}, {'date': '2018-07-26', 'size': 959446, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-22T12:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2018-06-13', 'resultsFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2018-06-13', 'lastUpdatePostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-28', 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance Visual Acuity (VA) (logMAR, OU)', 'timeFrame': 'Day 7, each product', 'description': 'VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.'}], 'secondaryOutcomes': [{'measure': 'Overall Vision', 'timeFrame': 'Day 7, each product', 'description': 'Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to sign an IRB/IEC approved Informed Consent form;\n* Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;\n* Experiencing symptoms of eye strain from using technology;\n* Willing to wear study lenses each day;\n* Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);\n* Willing to NOT use rewetting/lubricating drops at any time during the study;\n* Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;\n* Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.\n\nExclusion Criteria:\n\n* Conditions, use of medications, injury, or surgery, as specified in the protocol;\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* Monocular (only one eye with functional vision);\n* Pregnant.'}, 'identificationModule': {'nctId': 'NCT03567005', 'briefTitle': 'Clinical Validation of DACP Digital Design', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Validation of DACP Digital Design', 'orgStudyIdInfo': {'id': 'CLD523-C001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DACP Digital then DACP', 'description': 'Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.', 'interventionNames': ['Device: Nelfilcon A digital contact lenses', 'Device: Nelfilcon A contact lenses']}, {'type': 'OTHER', 'label': 'DACP then DACP Digital', 'description': 'Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.', 'interventionNames': ['Device: Nelfilcon A digital contact lenses', 'Device: Nelfilcon A contact lenses']}], 'interventions': [{'name': 'Nelfilcon A digital contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES® AquaComfort Plus® Digital', 'DACP Digital'], 'description': 'Silicone hydrogel digital contact lenses', 'armGroupLabels': ['DACP Digital then DACP', 'DACP then DACP Digital']}, {'name': 'Nelfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES® AquaComfort Plus®', 'DACP'], 'description': 'Silicone hydrogel spherical contact lenses', 'armGroupLabels': ['DACP Digital then DACP', 'DACP then DACP Digital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '43065', 'city': 'Powell', 'state': 'Ohio', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 40.15784, 'lon': -83.07519}}, {'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'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'}}}}