Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 1:13 AM
Study NCT ID:
NCT01379768
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-241-7629', 'title': 'Director of Alcon Clinical, Atlanta', 'organization': 'Alcon Research'}, 'certainAgreement': {'otherDetails': "For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study.', 'description': 'This reporting group includes all enrolled participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Leukocyte Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}], 'classes': [{'categories': [{'measurements': [{'value': '583187', 'spread': '832636', 'groupId': 'OG000'}, {'value': '420345', 'spread': '355940', 'groupId': 'OG001'}, {'value': '738140', 'spread': '609853', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.', 'unitOfMeasure': 'Leukocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes all participants who completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes all participants who completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes all participants who completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Change From Week 1 in Leukocyte Population at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1377', 'spread': '453,119', 'groupId': 'OG000'}, {'value': '-95301', 'spread': '632752', 'groupId': 'OG001'}, {'value': '122316', 'spread': '519976', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.', 'unitOfMeasure': 'Leukocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes all participants who completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes all participants who completed the study per protocol.'}, {'type': 'PRIMARY', 'title': 'Change From Week 1 in Relative Oxidative Response of PMNs at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'OG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes all participants who completed the study per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'FG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'FG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were recruited from one study center located in Canada.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'BG001', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.'}, {'id': 'BG002', 'title': 'No Lens Wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '50'}, {'value': '23.5', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '50'}, {'value': '23.5', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '41'}, {'value': '23', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '2011-06-09', 'resultsFirstSubmitDate': '2013-01-31', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-06', 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leukocyte Population', 'timeFrame': 'Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.'}, {'measure': 'Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)', 'timeFrame': 'Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.'}, {'measure': 'Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)', 'timeFrame': 'Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).'}, {'measure': 'Change From Week 1 in Leukocyte Population at Week 5', 'timeFrame': 'Week 1, Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.'}, {'measure': 'Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5', 'timeFrame': 'Week 1, Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.'}, {'measure': 'Change From Week 1 in Relative Oxidative Response of PMNs at Week 5', 'timeFrame': 'Week 1, Week 5', 'description': 'A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['White Blood Cells']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep. The results from contact lens wearers were compared with the results from non-contact lens wearers.', 'detailedDescription': 'The objective of the study was to determine and compare the relative oxidative response of polymorphonuclear neutrophils (PMNs), the relative cell adhesion response of PMNs, and the leukocyte population in tear samples collected from contact lens wearers and non-contact lens wearers. Tear samples were collected via a binocular eye-wash. The samples were processed, and a cell count was performed using a hemacytometer. Flow cytometry was used to determine the expression of different PMN cell markers before and after stimulation with bacterial lipopolysaccharide (LPS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 17 years of age or older.\n* Ocular examination in the last two years.\n* Has up-to-date spectacles.\n* Falls into one of the following three categories:\n\n * Adapted wearer of Lotrafilcon A contact lenses\n * Adapted wearer of Lotrafilcon B contact lenses\n * Does not wear contact lenses\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Ocular disease\n* Systemic or topical medications that may affect ocular health.\n* Known sensitivity to diagnostic pharmaceuticals used in study.\n* Uses artificial tears and/or rewetting drops.\n* Wears contact lenses on an overnight basis for more than one night per week.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01379768', 'acronym': 'CORNWALL', 'briefTitle': 'Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Polymorphonuclear Leukocyte Response During Overnight Lens Wear', 'orgStudyIdInfo': {'id': 'P-373-C-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lotrafilcon A', 'description': 'Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.', 'interventionNames': ['Device: Lotrafilcon A contact lens', 'Device: Clear Care Cleaning and Disinfection Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lotrafilcon B', 'description': 'Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.', 'interventionNames': ['Device: Lotrafilcon B contact lens', 'Device: Clear Care Cleaning and Disinfection Solution']}, {'type': 'NO_INTERVENTION', 'label': 'No lens wear', 'description': 'No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.'}], 'interventions': [{'name': 'Lotrafilcon A contact lens', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX NIGHT & DAY AQUA'], 'description': 'Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.', 'armGroupLabels': ['Lotrafilcon A']}, {'name': 'Lotrafilcon B contact lens', 'type': 'DEVICE', 'otherNames': ['NIGHT & DAY®'], 'description': 'Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.', 'armGroupLabels': ['Lotrafilcon B']}, {'name': 'Clear Care Cleaning and Disinfection Solution', 'type': 'DEVICE', 'otherNames': ['Clear Care®'], 'description': 'Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses', 'armGroupLabels': ['Lotrafilcon A', 'Lotrafilcon B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Waterloo Centre for Contact Lens Research', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD FCOptom FAAO, Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Contact Lens Research, School of Optometry, University of Waterloo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Waterloo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}