Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT04297618
Status:
COMPLETED
Last Update Posted:
2025-05-04
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575157', 'term': 'lifitegrast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jwoods@uwaterloo.ca', 'phone': '(519) 888-4567', 'title': 'Jill Woods', 'phoneExt': '36743', 'organization': 'Centre for Ocular Research and Education'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Regular investigator assessment', 'eventGroups': [{'id': 'EG000', 'title': 'Ocular Adverse Events (After Xiidra Was Dispensed)', 'description': 'Ocular adverse events in all participants who were dispensed with the study product.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 3, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Systemic Adverse Events (After Xiidra Was Dispensed)', 'description': 'Systemic adverse events in all participants who were dispensed with the study product.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 6, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ocular Adverse Events (Before Xiidra Was Dispensed)', 'description': 'Ocular adverse events that occurred in all participants that were eligible for the study prior to the study product being dispensed.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 1, 'seriousNumAtRisk': 43, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Systemic Adverse Events (Before Xiidra Was Dispensed)', 'description': 'Systemic adverse events that occurred in all participants that were eligible for the study prior to the study product being dispensed.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Irritated, red eye & purulent discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial conjunctivitis', 'notes': 'Bacterial conjunctivitis/Acute bacterial conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Watery eye', 'notes': 'Teary (watery) eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID', 'notes': 'COVID', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytoclastic vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dryness around periorbital eyelid skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal sterile infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infiltrative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xiidra Treatment', 'description': 'Each participant will use the same study drops, Xiidra, over the course of the 12-week study.\n\nXiidra: Xiidra (lifitegrast 5% ophthalmic solution)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '93'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '96'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants discontinued before the study could be completed.'}, {'type': 'PRIMARY', 'title': 'Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xiidra Treatment', 'description': 'Each participant will use the same study drops, Xiidra, over the course of the 12-week study.\n\nXiidra: Xiidra (lifitegrast 5% ophthalmic solution)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '96'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '98'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants discontinued before the study could be completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xiidra Treatment', 'description': 'Each participant will use the same study drops, Xiidra, over the course of the 12-week study.\n\nXiidra: Xiidra (lifitegrast 5% ophthalmic solution)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited at a single site between July 2021 and April 2024. The first participant was enrolled on July 7, 2021 and the last participant was enrolled January 19, 2024.', 'preAssignmentDetails': 'Out of the 45 participants that were enrolled, 43 met the inclusion critieria, and 42 were dispensed with the study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Xiidra Treatment', 'description': 'Each participant will use the same study drops, Xiidra, over the course of the 12-week study.\n\nXiidra: Xiidra (lifitegrast 5% ophthalmic solution)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '11.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', '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.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All suitable participants who were eligible to take part in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-29', 'size': 1379099, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-17T14:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2020-03-03', 'resultsFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-21', 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).'}, {'measure': 'Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Is at least 18 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. Currently wears daily, soft, frequent replacement lenses (daily, bi-weekly or monthly disposable lenses) in both eyes, that are available in Canada, for a minimum of 5 days/week for 6 hours/day over the last month, and is willing to continue to do so during the study;\n5. Is a symptomatic CL wearer as determined by Eye Dryness Score4,5 (EDS) ≥40 at the end of the wear day AND according to the classification by Young et al7;\n6. Can achieve acceptable lens fit as well as visual acuity (VA) correctable to logMAR +0.20 or better in each eye with their habitual contact lens type;\n7. Has a history of artificial tear or rewetting drop use at least once in the last 30 days;\n8. Is willing to use the Xiidra study drops twice a day on a daily basis (irrespective of CL wear) and to stop use of any habitual rewetting drops and/or artificial tears over the course of the 12-week treatment phase;\n\nExclusion Criteria:\n\n1. Is participating in any concurrent clinical or research study;\n2. Is wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gas permeable lens or hybrid lens wearer;\n3. Has a known sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study;\n4. Has any known ocular disease and/or infection, that's either currently active\\* or has occurred within the previous 30 days;\n5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (examples may include active or uncontrolled systemic conditions such as allergies, autoimmune disease or immunodeficiency disease);\n6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable, including but not limited to topical cyclosporine, any other topical ophthalmic medication, antihistamines, and aspirin;\n7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);\\*\\*\n8. Has undergone refractive error surgery such as LASIK within the last 12 months;\n9. Has a history of yttrium-aluminium-garnet laser posterior capsulotomy within the previous 6 months,\n10. Is an employee of the Centre for Ocular Research \\& Education; \\* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active."}, 'identificationModule': {'nctId': 'NCT04297618', 'acronym': 'COLLIE', 'briefTitle': 'The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers', 'orgStudyIdInfo': {'id': '41189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xiidra treatment', 'description': 'Each participant will use the same study drops, Xiidra, over the course of the 12-week study.', 'interventionNames': ['Drug: Xiidra']}], 'interventions': [{'name': 'Xiidra', 'type': 'DRUG', 'otherNames': ['Lifitegrast'], 'description': 'Xiidra (lifitegrast 5% ophthalmic solution)', 'armGroupLabels': ['Xiidra treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Ocular Research & Education', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD, FCOptom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Ocular Research & Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Waterloo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}