Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05705518
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2023-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Artificial Tears, Tear Lipids and Tear Film Dynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agraham@berkeley.edu', 'phone': '510-643-9252', 'title': 'Andrew D. Graham', 'organization': 'University of California Berkeley Clinical Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were recorded for each subject monthly for 8 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Run-in Period Participants', 'description': 'All subjects participate in a 1-week run-in period during which they used a common over-the-counter non-lipid artificial tear (Systane Ultra PF). Upon completion of the run-in period, participants will then be randomized to one of the 4 study solutions.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tear Lipid Layer Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG001', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product'}, {'id': 'OG002', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG003', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '-2.48', 'upperLimit': '3.93'}, {'value': '-7.58', 'groupId': 'OG001', 'lowerLimit': '-11.46', 'upperLimit': '-3.70'}, {'value': '2.06', 'groupId': 'OG002', 'lowerLimit': '-0.83', 'upperLimit': '4.95'}, {'value': '1.41', 'groupId': 'OG003', 'lowerLimit': '-1.50', 'upperLimit': '4.32'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change in Tear Lipid Layer Thickness (3mo follow-up - post-run-in baseline)', 'unitOfMeasure': 'nm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tear Lipid Layer Uniformity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG001', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product'}, {'id': 'OG002', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG003', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.66', 'upperLimit': '0.37'}, {'value': '-0.77', 'groupId': 'OG001', 'lowerLimit': '-1.47', 'upperLimit': '-0.06'}, {'value': '-0.01', 'groupId': 'OG002', 'lowerLimit': '-0.58', 'upperLimit': '0.56'}, {'value': '-0.23', 'groupId': 'OG003', 'lowerLimit': '-0.70', 'upperLimit': '0.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change (3mo follow-up - post-run-in baseline) in Tear Lipid Layer Thickness Coefficient of Variation (CV). The CV is calculated as the standard deviation divided by the mean lipid layer thickness. A greater value of the CV indicates more variability in lipid layer thickness, a smaller value of the CV indicates a more uniformly thick lipid layer.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tear Film Thinning Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG001', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product'}, {'id': 'OG002', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG003', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '-0.55', 'upperLimit': '1.22'}, {'value': '1.71', 'groupId': 'OG001', 'lowerLimit': '1.04', 'upperLimit': '2.38'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '-0.81', 'upperLimit': '0.85'}, {'value': '0.70', 'groupId': 'OG003', 'lowerLimit': '-0.13', 'upperLimit': '1.53'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Tear Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change in Tear Film Thinning rate (3mo follow-up - post-run-in baseline)', 'unitOfMeasure': '% Area of Fluorescein Darkening / sec', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Subjective Symptoms - OSDI Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG001', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product'}, {'id': 'OG002', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG003', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product'}], 'classes': [{'categories': [{'measurements': [{'value': '2.88', 'spread': '13.45', 'groupId': 'OG000'}, {'value': '4.90', 'spread': '16.31', 'groupId': 'OG001'}, {'value': '2.79', 'spread': '15.22', 'groupId': 'OG002'}, {'value': '1.30', 'spread': '9.48', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change (3mo follow-up - post-run-in baseline) in Ocular Surface Disease Index (OSDI) score. The OSDI questionnaire score ranges from 0-100, with higher scores indicating more severe symptoms of Dry Eye Disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Subjective Symptoms - SANDE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG001', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product'}, {'id': 'OG002', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG003', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product'}], 'timeFrame': 'SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change in Symptom Assessment questionnaire iN Dry Eye (SANDE) score (3mo follow-up - post-run-in baseline)', 'reportingStatus': 'POSTED', 'populationDescription': 'The SANDE questionnaire was not administered to any subjects due to logistical issues.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory - Subjective Symptoms - DEQ-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG001', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product'}, {'id': 'OG002', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'OG003', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product'}], 'timeFrame': 'DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change in 5-Item Dry Eye Questionnaire (DEQ-5) score (3mo follow-up - post-run-in baseline)', 'reportingStatus': 'POSTED', 'populationDescription': 'The DEQ-5 questionnaire was not administered to any subjects due to logistical issues.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Run-in Period Participants', 'description': 'All subjects participate in a 1-week run-in period during which they used a common over-the-counter non-lipid artificial tear (Systane Ultra PF). Upon completion of the run-in period, participants will then be randomized to one of the 4 study solutions.'}, {'id': 'FG001', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'FG002', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product'}, {'id': 'FG003', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'FG004', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product'}], 'periods': [{'title': '1-week Run-in Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Post-run-in Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All subjects participated in a 1-week run-in period during which they used a common over-the-counter non-lipid artificial tear (Systane Ultra PF). Upon completion of the run-in period, participants were then randomized to one of the 4 study solutions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nSystane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'BG001', 'title': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product'}, {'id': 'BG002', 'title': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nRefresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product'}, {'id': 'BG003', 'title': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.\n\nCVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '16.1', 'groupId': 'BG000'}, {'value': '34.0', 'spread': '16.6', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '17.1', 'groupId': 'BG002'}, {'value': '35.5', 'spread': '17.3', 'groupId': 'BG003'}, {'value': '36.0', 'spread': '16.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity Group', 'categories': [{'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'Non-Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-02', 'size': 318058, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-14T15:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'After the 1-week initial period during which all subjects will use the run-in solution, subjects will be randomly assigned one of the 4 study solutions, and neither the subject nor the clinician researchers or technicians conducting examinations and taking measurements will be aware of which solution is assigned. All 4 solutions will be dispensed in color- and name-coded identical dispensing bottles prepared by study personnel not involved in collecting data.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2023-01-20', 'resultsFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-03', 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory - Subjective Symptoms - OSDI Questionnaire', 'timeFrame': 'OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change (3mo follow-up - post-run-in baseline) in Ocular Surface Disease Index (OSDI) score. The OSDI questionnaire score ranges from 0-100, with higher scores indicating more severe symptoms of Dry Eye Disease.'}, {'measure': 'Exploratory - Subjective Symptoms - SANDE', 'timeFrame': 'SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change in Symptom Assessment questionnaire iN Dry Eye (SANDE) score (3mo follow-up - post-run-in baseline)'}, {'measure': 'Exploratory - Subjective Symptoms - DEQ-5', 'timeFrame': 'DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change in 5-Item Dry Eye Questionnaire (DEQ-5) score (3mo follow-up - post-run-in baseline)'}], 'primaryOutcomes': [{'measure': 'Tear Lipid Layer Thickness', 'timeFrame': 'Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change in Tear Lipid Layer Thickness (3mo follow-up - post-run-in baseline)'}], 'secondaryOutcomes': [{'measure': 'Tear Lipid Layer Uniformity', 'timeFrame': 'Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change (3mo follow-up - post-run-in baseline) in Tear Lipid Layer Thickness Coefficient of Variation (CV). The CV is calculated as the standard deviation divided by the mean lipid layer thickness. A greater value of the CV indicates more variability in lipid layer thickness, a smaller value of the CV indicates a more uniformly thick lipid layer.'}, {'measure': 'Tear Film Thinning Rate', 'timeFrame': 'Tear Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit', 'description': 'Change in Tear Film Thinning rate (3mo follow-up - post-run-in baseline)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Tear Film Lipid Layer Dynamics', 'Tear Film Stability'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'Dry eye disease (DED) is pervasive with some reports estimating over 16 million adults diagnosed in the United States. Currently, artificial tears remain an integral part of managing dry eyes and are mainly used for symptomatic relief. Recent studies have shown there may be therapeutic benefits with regular use of lipid-based artificial tears to improve the structure of the tear film, which may improve tear film stability and provide relief of symptoms. In this study the investigators propose to compare effects on the tear lipid film and its dynamics between 3 lipid based artificial tears and a widely available non-lipid based artificial tear.', 'detailedDescription': 'This is a prospective, double-masked, randomized, controlled, parallel-group trial designed to compare the impact of Systane Complete PF lipid-based artificial tears (the Treatment solution under study) on tear lipid layer thickness compared with a non-lipid Control solution, Refresh Relieva PF. Secondarily, the study will compare changes in tear lipid layer thickness, lipid layer uniformity, tear film thinning dynamics, and symptoms between the Treatment solution, the non-lipid Control solution, and 2 other available lipid-based solutions (Active Comparators: Refresh Optive Mega-3 PF and CVS Health Lubricant Eye Drop (PG 0.6%)). The study will include 4 clinic visits, and require 1 week of single-masked run-in with Systane Ultra PF (an over-the-counter non-lipid-based solution) followed by 3 months of study treatment dosing. All subjects will complete a screening interview, then an in-clinic baseline ocular health examination and study eligibility determination followed by dispensing of the Control solution to all subjects for 1 week of run-in. After that week, subjects will be randomized to 1 of the 4 artificial tear solutions and have an in-clinic ocular examination and dispense of the assigned solution to use for 3 months. An in-clinic follow-up examination is completed after 1 month of study solution use, followed by a phone interview at 2 months, and a final in-clinic examination at 3 months post-dispensing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Best Corrected Visual Acuity of 20/30 or better;\n* Experiencing Dry Eye symptoms (baseline OSDI score \\>= 13);\n\nExclusion Criteria:\n\n* Currently experiencing active ocular inflammation or infection;\n* Currently using topical eye medication (not including over-the-counter eyedrops);\n* Having systemic health conditions or using prescription medications (including but not limited to isotretinoin derivatives) that could alter tear film physiology;\n* Having a history of severe ocular trauma, ocular surgery, or diabetes;\n* Being pregnant or breast feeding;\n* Being a current contact lens wearer;\n* Currently having a condition or being in a situation which, in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may otherwise significantly interfere with their participation in the study;"}, 'identificationModule': {'nctId': 'NCT05705518', 'acronym': 'AlconAT', 'briefTitle': 'Artificial Tears, Tear Lipids and Tear Film Dynamics', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'Effects Of Artificial Tears on Tear Lipid Films and Tear Film Dynamics In Vivo', 'orgStudyIdInfo': {'id': 'CPHS_2022-09-15617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systane Complete PF (Treatment)', 'description': 'Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.', 'interventionNames': ['Drug: Systane Complete PF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Refresh Relieva PF (Control)', 'description': 'Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.', 'interventionNames': ['Drug: Refresh Relieva PF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Refresh Optive Mega-3 PF (Active Comparator 1)', 'description': 'Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.', 'interventionNames': ['Drug: Refresh Optive Mega-3 PF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)', 'description': 'Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.', 'interventionNames': ['Drug: CVS Health Lubricant Eye Drop (PG 0.6%)']}], 'interventions': [{'name': 'Systane Complete PF', 'type': 'DRUG', 'description': '3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product', 'armGroupLabels': ['Systane Complete PF (Treatment)']}, {'name': 'Refresh Relieva PF', 'type': 'DRUG', 'description': '3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product', 'armGroupLabels': ['Refresh Relieva PF (Control)']}, {'name': 'Refresh Optive Mega-3 PF', 'type': 'DRUG', 'description': '3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product', 'armGroupLabels': ['Refresh Optive Mega-3 PF (Active Comparator 1)']}, {'name': 'CVS Health Lubricant Eye Drop (PG 0.6%)', 'type': 'DRUG', 'description': '3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product', 'armGroupLabels': ['CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94720-2020', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Center, School of Optometry, University of California, Berkeley', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'Meng C. Lin, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California Berkeley Clinical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified data collected in this study may be shared upon request, at the discretion of the PI, for non-commercial research purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}