Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT05166902
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega2@coopervision.com', 'phone': '9256213761', 'title': 'Jose A Vega, OD, MSc, FAAO', 'organization': 'CooperVision'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to one month on each study lens, for total of two months', 'description': '\\[Not Specified\\]', 'eventGroups': [{'id': 'EG000', 'title': 'Lens A', 'description': 'Participants wore Lens A for one month', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 4, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lens B', 'description': 'Participants wore Lens B for one month', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 2, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lens discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Ratings on Lens Handling on Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens A', 'description': 'Participants wore Lens A for 1 month.'}, {'id': 'OG001', 'title': 'Lens B', 'description': 'Participants wore Lens B for 1 month.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 27', 'description': 'Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lens A, Then Lens B', 'description': 'Participants wore Lens A for one month and then crossed over to wear Lens B for one month.'}, {'id': 'FG001', 'title': 'Lens B, Then Lens A', 'description': 'Participants wore Lens B for one month and then crossed over to wear Lens A for one month.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Sixty-seven participants were screened with no screen failures. One participant discontinued and the remaining 66 all completed the study.\n\nAll the participants who completed the study were included in the analysis. (Analysis population n=66)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Analysis Population', 'description': 'Sixty-six participants completed the study, and demographic data include all participants who completed the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Sixty-six participants completed the study, and demographic data include all participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-17', 'size': 2452457, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-30T12:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2021-12-08', 'resultsFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-24', 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Ratings on Lens Handling on Removal', 'timeFrame': 'Day 27', 'description': 'Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ametropia']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.', 'detailedDescription': 'This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is at least 18 years of age and no older than 35 years, 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. Self-reports having a full eye examination in the previous two years;\n5. Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;\n6. Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;\n7. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;\n8. Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: The habitual contact lens brand was restricted such that no more than one third were to be Biofinity Energys brand (or their equivalent private label brand name) and no more than one third were to be Alcon brand);\n9. Has refractive astigmatism no higher than -0.75DC in each eye;\n10. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).\n\nExclusion Criteria:\n\n1. Is participating in any concurrent clinical or research study;\n2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;\n3. Has a systemic or ocular 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 contact lens wear or a study outcome variable;\n5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;\n6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;\n7. Has undergone refractive error surgery or intraocular surgery.'}, 'identificationModule': {'nctId': 'NCT05166902', 'briefTitle': 'Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Evaluation of Monthly Replacement Lens Designs in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use', 'orgStudyIdInfo': {'id': 'EX-MKTG-130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens A, Then Lens B', 'description': 'Participants will wear lens A for one month and then cross over to wear lens B for one month.', 'interventionNames': ['Device: Lens A (comfilcon A lens)', 'Device: Lens B (lehfilcon A lens)']}, {'type': 'EXPERIMENTAL', 'label': 'Lens B, Then Lens A', 'description': 'Participants will wear lens B for one month and then cross over to wear lens A for one month.', 'interventionNames': ['Device: Lens A (comfilcon A lens)', 'Device: Lens B (lehfilcon A lens)']}], 'interventions': [{'name': 'Lens A (comfilcon A lens)', 'type': 'DEVICE', 'description': '1 month', 'armGroupLabels': ['Lens A, Then Lens B', 'Lens B, Then Lens A']}, {'name': 'Lens B (lehfilcon A lens)', 'type': 'DEVICE', 'description': '1 month', 'armGroupLabels': ['Lens A, Then Lens B', 'Lens B, Then Lens A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Coan Eye Care', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '168801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Nittany Eye Associate', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': 'M2N 3A4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Eyes on Sheppard Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5V 3E7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Spadina Optometry', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'David Wilkinson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spadina Optometry'}, {'name': 'Roxanne Achong-Coan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coan Eyecare'}, {'name': 'Fiona Soong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eyes on Sheppard Clinic'}, {'name': 'Mike Cymbor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nittany Eye Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centre for Ocular Research & Education, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}