Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-17 @ 6:16 PM
Study NCT ID:
NCT04037969
Status:
COMPLETED
Last Update Posted:
2021-04-23
First Post:
2019-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jwoods@uwaterloo.ca', 'phone': '5198884567', 'title': 'Jill Woods', 'phoneExt': '36743', 'organization': 'Centre for Ocular Research and Education'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'One day', 'eventGroups': [{'id': 'EG000', 'title': 'Nesofilcon A/Delefilcon A', 'description': 'Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye.\n\nNesofilcon A: Hydrogel contact lens for daily wear', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Delefilcon A/Nesofilcon A', 'description': 'Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye.\n\nDelefilcon A: Silicone hydrogel contact lens for daily wear', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tear Evaporation Rate With Nesofilcon A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Group', 'description': 'Delefilcon A was worn in a randomly assigned eye and Nesofilcon A was worn in the fellow eye.\n\nNesofilcon A: Hydrogel contact lens for daily wear\n\nDelefilcon A: Silicone hydrogel contact lens for daily wear'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': '15 minutes post-contact lenses', 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': '6 hours post-contact lenses', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 minutes post-contact lens, 6 hours post-contact lens', 'description': 'Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.', 'unitOfMeasure': '% relative humidity per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tear Evaporation Rate With Delefilcon A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Group', 'description': 'Delefilcon A was worn in a randomly assigned eye and Nesofilcon A was worn in the fellow eye.\n\nNesofilcon A: Hydrogel contact lens for daily wear\n\nDelefilcon A: Silicone hydrogel contact lens for daily wear'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': '15 minutes post-contact lenses', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': '6 hours post-contact lenses', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 minutes post-contact lens, 6 hours post-contact lens', 'description': 'Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.', 'unitOfMeasure': '% relative humidity per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nesofilcon A/Delefilcon A', 'description': 'Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye.\n\nNesofilcon A: Hydrogel contact lens for daily wear'}, {'id': 'FG001', 'title': 'Delefilcon A/Nesofilcon A', 'description': 'Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye.\n\nDelefilcon A: Silicone hydrogel contact lens for daily wear'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nesofilcon A/Delefilcon A', 'description': 'Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye.\n\nNesofilcon A: Hydrogel contact lens for daily wear'}, {'id': 'BG001', 'title': 'Delefilcon A/Nesofilcon A', 'description': 'Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye.\n\nDelefilcon A: Silicone hydrogel contact lens for daily wear'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.2', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '28.2', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-24', 'size': 2888802, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-11T11:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants and investigators are masked as to which lens is assigned to each eye.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-25', 'studyFirstSubmitDate': '2019-07-26', 'resultsFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-25', 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear Evaporation Rate With Nesofilcon A', 'timeFrame': 'Baseline, 15 minutes post-contact lens, 6 hours post-contact lens', 'description': 'Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.'}, {'measure': 'Tear Evaporation Rate With Delefilcon A', 'timeFrame': 'Baseline, 15 minutes post-contact lens, 6 hours post-contact lens', 'description': 'Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Evaporative Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is at least 17 years of age and has full legal capacity to volunteer;\n2. Has read and signed an information consent letter;\n3. Is willing and able to follow instructions and maintain the appointment schedule;\n4. Has worn soft contact lenses for a minimum of 6 months;\n5. Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;\n6. Has an acceptable fit and comfort with both study contact lenses in the powers available;\n7. Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses;\n8. Is willing to be awake for at least 2 hours before visit 2;\n9. Is willing to not wear eye makeup on the day of visit 2 and 3;\n10. Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3;\n11. Has a wearable pair of spectacles.\n\nExclusion Criteria:\n\n1. Is participating in any concurrent clinical or research study;\n2. Has any known active\\* ocular disease and/or infection;\n3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;\n4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;\n5. Has known sensitivity to sodium fluorescein dye;\n6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);\n7. Is aphakic;\n8. Has undergone refractive error surgery;\n9. Has a known sensitivity to petroleum jelly (Vaseline);\n10. Has epilepsy and/or a sensitivity to flashing lights;\n11. Wears toric contact lenses;\n12. Has any physical impairment that would interfere with holding the evaporimeter;\n13. Has taken part in another research study within the last 14 days.'}, 'identificationModule': {'nctId': 'NCT04037969', 'acronym': 'MALTESE', 'briefTitle': 'Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday', 'orgStudyIdInfo': {'id': '41195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nesofilcon A/Delefilcon A', 'description': 'Nesofilcon A was worn in right eye and delefilcon A worn in the left eye.', 'interventionNames': ['Device: Nesofilcon A', 'Device: Delefilcon A']}, {'type': 'EXPERIMENTAL', 'label': 'Delefilcon A/Nesofilcon A', 'description': 'Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye.', 'interventionNames': ['Device: Nesofilcon A', 'Device: Delefilcon A']}], 'interventions': [{'name': 'Nesofilcon A', 'type': 'DEVICE', 'description': 'Hydrogel contact lens for daily wear', 'armGroupLabels': ['Delefilcon A/Nesofilcon A', 'Nesofilcon A/Delefilcon A']}, {'name': 'Delefilcon A', 'type': 'DEVICE', 'description': 'Silicone hydrogel contact lens for daily wear', 'armGroupLabels': ['Delefilcon A/Nesofilcon A', 'Nesofilcon A/Delefilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Ocular Research & Education', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Waterloo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}