Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01494818
Status:
COMPLETED
Last Update Posted:
2013-09-27
First Post:
2011-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D003263', 'term': 'Contact Lenses, Hydrophilic'}], 'ancestors': [{'id': 'D003261', 'term': 'Contact Lenses'}, {'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Renee Garofalo, OD, FAAO', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product.', 'description': 'An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months", 'otherNumAtRisk': 39, 'otherNumAffected': 3, 'seriousNumAtRisk': 39, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months", 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Toxic reaction to solution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Papillae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'OG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'classes': [{'title': 'Baseline (habitual contact lenses and care system)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \\& tufts papillae); 3 = Moderate (moderate \\& tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants who completed the study as per protocol'}, {'type': 'PRIMARY', 'title': 'Maximum Eyelid Hyperaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'OG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'classes': [{'title': 'Baseline (habitual contact lenses and care system)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants who completed the study as per protocol'}, {'type': 'SECONDARY', 'title': 'Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'OG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'classes': [{'title': 'Baseline (habitual contact lenses and care system)', 'categories': [{'measurements': [{'value': '4.05', 'spread': '4.63', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '32.00'}, {'value': '5.08', 'spread': '4.07', 'groupId': 'OG001', 'lowerLimit': '1.20', 'upperLimit': '16.60'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '5.76', 'spread': '4.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '24.70'}, {'value': '4.22', 'spread': '2.12', 'groupId': 'OG001', 'lowerLimit': '1.30', 'upperLimit': '12.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants who completed the study as per protocol'}, {'type': 'PRIMARY', 'title': 'Upper Lid Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'OG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'classes': [{'title': 'Baseline (habitual contact lenses and care system)', 'categories': [{'measurements': [{'value': '34.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '35.2', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.', 'unitOfMeasure': 'Percentage of total surface measured', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants who completed the study as per protocol'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Upper Eyelid Margin Staining at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'OG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.014', 'spread': '3.905', 'groupId': 'OG000'}, {'value': '-0.754', 'spread': '4.179', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.', 'unitOfMeasure': 'square millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants who completed the study as per protocol'}, {'type': 'SECONDARY', 'title': 'Protective Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'OG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'classes': [{'title': 'Baseline (habitual contact lenses and care system)', 'categories': [{'measurements': [{'value': '95.9', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '95.8', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '96.4', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '97.8', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.', 'unitOfMeasure': 'Percent of visible contact lens surface', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants who completed the study as per protocol'}, {'type': 'SECONDARY', 'title': 'Median Front Lens Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'OG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'classes': [{'title': 'Baseline (habitual contact lenses and care system)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants who completed the study as per protocol'}, {'type': 'SECONDARY', 'title': 'Total Lipid Uptake Per Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'OG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'classes': [{'title': 'Baseline (habitual contact lenses and care system)', 'categories': [{'measurements': [{'value': '38.95', 'spread': '23.94', 'groupId': 'OG000', 'lowerLimit': '4.121', 'upperLimit': '95.504'}, {'value': '36.44', 'spread': '47.59', 'groupId': 'OG001', 'lowerLimit': '4.150', 'upperLimit': '97.875'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '32.40', 'spread': '24.53', 'groupId': 'OG000'}, {'value': '34.20', 'spread': '26.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.', 'unitOfMeasure': 'micrograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants who completed the study as per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'FG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from one study center located in the United Kingdom.', 'preAssignmentDetails': 'Of the 79 participants enrolled in the study, 1 participant exited the study between enrollment and product dispensing due to nonavailability. This reporting group includes all enrolled and dispensed participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'BG001', 'title': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '35.5', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '35.1', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This reporting group includes all enrolled and dispensed participants who completed the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-30', 'studyFirstSubmitDate': '2011-12-15', 'resultsFirstSubmitDate': '2013-07-30', 'studyFirstSubmitQcDate': '2011-12-16', 'lastUpdatePostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-30', 'studyFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Papillae', 'timeFrame': 'Baseline, Month 3', 'description': 'Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \\& tufts papillae); 3 = Moderate (moderate \\& tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.'}, {'measure': 'Maximum Eyelid Hyperaemia', 'timeFrame': 'Baseline, Month 3', 'description': 'Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.'}, {'measure': 'Upper Lid Redness', 'timeFrame': 'Baseline, Month 3', 'description': 'The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.'}, {'measure': 'Change From Baseline in Upper Eyelid Margin Staining at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': 'The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.'}], 'secondaryOutcomes': [{'measure': 'Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)', 'timeFrame': 'Baseline, Month 3', 'description': 'The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.'}, {'measure': 'Protective Index', 'timeFrame': 'Baseline, Month 3', 'description': 'A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.'}, {'measure': 'Median Front Lens Deposits', 'timeFrame': 'Baseline, Month 3', 'description': 'Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.'}, {'measure': 'Total Lipid Uptake Per Lens', 'timeFrame': 'Baseline, Month 3', 'description': 'The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lenses', 'Contact lens solutions'], 'conditions': ['Contact Lens Care']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.', 'detailedDescription': "The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Read and understand Participant Information Sheet;\n* Read, sign, and date Informed Consent;\n* Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality;\n* Using a PHMB-containing multipurpose contact lens solution;\n* Symptomatic, as specified in protocol;\n* Best corrected visual acuity of 6/9 or better in each eye;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any known sensitivity or intolerance to the contact lenses or len care products to be used;\n* Systemic disease/medication which might interfere with contact lens wear or produce dry eye side effects;\n* Ocular allergies or ocular disease which might interfere with contact lens wear;\n* Use of any concomitant topical ocular medications during the study period;\n* Participation in an investigational drug or device study within 30 days of entering the study;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01494818', 'briefTitle': 'Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Evaluation of the Effects of Clear Care/AOSEPT Plus Hydrogen Peroxide Solution on the Eyelid Tissues - Part II: Comparative Evaluation With RENU MPS Over 3 Months of Wear', 'orgStudyIdInfo': {'id': 'ID 10-59 / M-11-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLEAR CARE/AOSEPT Plus', 'description': "Hydrogen peroxide-based contact lens care system used per manufacturer's instructions", 'interventionNames': ['Device: Hydrogen peroxide-based contact lens care system', 'Device: Soft contact lenses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ReNu MultiPlus', 'description': "PHMB-containing contact lens solution used per manufacturer's instructions", 'interventionNames': ['Device: PHMB-containing contact lens solution', 'Device: Soft contact lenses']}], 'interventions': [{'name': 'Hydrogen peroxide-based contact lens care system', 'type': 'DEVICE', 'otherNames': ['CLEAR CARE®/AOSEPT Plus'], 'armGroupLabels': ['CLEAR CARE/AOSEPT Plus']}, {'name': 'PHMB-containing contact lens solution', 'type': 'DEVICE', 'otherNames': ['ReNu® MultiPlus Multi-Purpose solution'], 'armGroupLabels': ['ReNu MultiPlus']}, {'name': 'Soft contact lenses', 'type': 'DEVICE', 'description': 'Contact lenses identical to habitual prescription worn per usual replacement regimen', 'armGroupLabels': ['CLEAR CARE/AOSEPT Plus', 'ReNu MultiPlus']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michel Guillon, PhD, FCOptom, FAAO, CCTI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OTG Research & Consultancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}