Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT00937105
Status:
COMPLETED
Last Update Posted:
2014-03-10
First Post:
2009-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Daily Wear Corneal Infiltrative Event Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'loretta.szczotka@uhhospitals.org', 'phone': '216-844-3609', 'title': 'Loretta Szczotka-Flynn OD, PhD', 'organization': 'University Hospitals Eye Institute'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Mostly asymptomatic CIE events occurred which limited the ability to retrieve the lens worn (for culture) precisely at the time of CIE development; this may have hindered our ability to capture bioburden at the time of the adverse event.'}}, 'adverseEventsModule': {'timeFrame': 'up to 1 year', 'description': 'CIE definitions adopted from the standards as listed in the "Institute for Eye Research/L.V. Prasad Eye Institute (IER/LVPEI) Guide To Corneal Infiltrative Conditions\n\nContact Lens Papillary Conjunctivitis was a clinical diagnosis that required temporary or permanent discontinuation of lens wear due to large papilla upon upper lid eversion', 'eventGroups': [{'id': 'EG000', 'title': 'Entire Cohort of Lotrafilcon A Users', 'otherNumAtRisk': 218, 'otherNumAffected': 23, 'seriousNumAtRisk': 218, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'corneal infiltrative event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 12}], 'organSystem': 'Eye disorders'}, {'term': 'Contact Lens Papillary Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 11}], 'organSystem': 'Eye disorders'}], 'seriousEvents': [{'term': 'microbial keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Developing a Corneal Inflammatory Event (CIE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A Lenses and Renu'}, {'id': 'OG001', 'title': 'Lotrafilcon A Lenses and Clear Care'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '96.5'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cumulative Probability of no-CIE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.8', 'ciLowerLimit': '88.6', 'ciUpperLimit': '96.9', 'groupDescription': 'Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort', 'statisticalMethod': 'Kaplan-Meier', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cumulative Unadjusted Probability of remaining CIE-free presented for entire cohort (both solution groups) to remain consistent with the primary aim', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Raw number of participants in each solution arm developing CIE over 12 month follow-up period', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This primary analysis includes the cohort of all 218 randomized participants. The measured values stratify participants by solution group, however, the statistical analysis reports on the entire cohort (both solution groups) consistent with the primary aim of the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CIE Stratified by Microbial Bioburden on Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Microbial Bioburden on Lenses'}, {'id': 'OG001', 'title': 'Participants Without Microbial Bioburden on Lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.490', 'upperLimit': '6.156'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3923', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.737', 'ciLowerLimit': '0.49', 'ciUpperLimit': '6.156', 'estimateComment': 'referent is no substantial lens bioburden', 'groupDescription': 'To determine if microbial contamination of lenses is a risk factor for CIE', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in which valid lens bioburden data was available'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Corneal Staining'}, {'id': 'OG001', 'title': 'Participants Without Corneal Staining'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.167', 'upperLimit': '10.393'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7943', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.316', 'ciLowerLimit': '0.167', 'ciUpperLimit': '10.393', 'estimateComment': 'referent is no corneal staining', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with valid presumed solution induced corneal staining data in each group'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Microbial Bioburden on Lens Cases'}, {'id': 'OG001', 'title': 'Participants With no Microbial Bioburden on Lens Cases'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0.161', 'upperLimit': '2.822'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5894', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.674', 'ciLowerLimit': '0.161', 'ciUpperLimit': '2.822', 'estimateComment': 'referent is no substantial case bioburden', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in which valid lens case bioburden data was available'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Microbial Bioburden on Lid Margins'}, {'id': 'OG001', 'title': 'Participants With no Microbial Bioburden on Lid Margins'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '24.70'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1742', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.406', 'ciLowerLimit': '0.678', 'ciUpperLimit': '8.537', 'pValueComment': 'Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses', 'estimateComment': 'referent is no substantial overall lid bioburden', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in which valid lens bioburden data was available'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With CNS Bioburden on Lid Margins'}, {'id': 'OG001', 'title': 'Participants With no CNS Bioburden on Lid Margins'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.22', 'ciLowerLimit': '1.10', 'ciUpperLimit': '24.70', 'estimateComment': 'referent is no substantial CNS lid bioburden', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multivariate model adjusted for solution, gender and age', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in which valid lids bioburden data was available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lotrafilcon A Lenses and Clear Care'}, {'id': 'FG001', 'title': 'Lotrafilcon A Lenses and Renu Multiplus'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}]}], 'recruitmentDetails': 'From November 2009 to February 2012, 218 participants were randomized at the University Hospitals Case Medical Center Eye Institute.', 'preAssignmentDetails': 'Existing soft lens wearers or non contact lens wearers were recruited, no wash out period was required'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lotrafilcon A and Renu'}, {'id': 'BG001', 'title': 'Lotrafilcon A and Clear Care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.4', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '34.9', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The baseline measures refer to the entire cohort of 218 participants that were randomized, stratified by solution group'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-27', 'studyFirstSubmitDate': '2009-07-09', 'resultsFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2009-07-09', 'lastUpdatePostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-27', 'studyFirstPostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Developing a Corneal Inflammatory Event (CIE)', 'timeFrame': 'up to 1 year', 'description': 'Raw number of participants in each solution arm developing CIE over 12 month follow-up period'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With CIE Stratified by Microbial Bioburden on Lenses', 'timeFrame': 'up to 1 year', 'description': 'Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses'}, {'measure': 'Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.', 'timeFrame': 'up to 1 year', 'description': 'Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones'}, {'measure': 'Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases', 'timeFrame': 'up to 1 year', 'description': 'Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora'}, {'measure': 'Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins', 'timeFrame': 'up to 1 year', 'description': 'Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids'}, {'measure': 'Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins', 'timeFrame': 'up to 1 year', 'description': 'Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myopia', 'Hyperopia', 'Corneal Infiltrative Events']}, 'referencesModule': {'references': [{'pmid': '24240354', 'type': 'RESULT', 'citation': 'Szczotka-Flynn L, Jiang Y, Raghupathy S, Bielefeld RA, Garvey MT, Jacobs MR, Kern J, Debanne SM. Corneal inflammatory events with daily silicone hydrogel lens wear. Optom Vis Sci. 2014 Jan;91(1):3-12. doi: 10.1097/OPX.0000000000000105.'}, {'pmid': '24756119', 'type': 'DERIVED', 'citation': 'Jiang Y, Jacobs M, Bajaksouzian S, Foster AN, Debanne SM, Bielefeld R, Garvey M, Raghupathy S, Kern J, Szczotka-Flynn LB. Risk factors for microbial bioburden during daily wear of silicone hydrogel contact lenses. Eye Contact Lens. 2014 May;40(3):148-56. doi: 10.1097/ICL.0000000000000026.'}]}, 'descriptionModule': {'briefSummary': 'This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night \\& Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use will be followed for 1 year. The primary outcome is the risk of development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is microbial contamination of study lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient must be at least 15 years old.\n2. The patient must be free of any anterior segment disorders.\n3. The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder.\n4. The patient must be correctable to 20/25 or better with spectacles.\n5. Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.\n6. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.\n\nExclusion Criteria\n\n1. The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.\n2. The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months.\n3. The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.\n4. The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation.\n5. The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.\n6. The patient is taking any ocular medications. If a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.\n7. The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use.\n8. The patient is pregnant."}, 'identificationModule': {'nctId': 'NCT00937105', 'acronym': 'DWCIE', 'briefTitle': 'Daily Wear Corneal Infiltrative Event Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ReNu Multiplus and lotrafilcon A lenses', 'description': 'ReNu Multiplus contact lens care solution', 'interventionNames': ['Device: lotrafilcon A contact lenses', 'Device: Renu Multiplus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clear Care solution and lotrafilcon A lenses', 'description': 'Clear Care Contact Lens Care Solution', 'interventionNames': ['Device: lotrafilcon A contact lenses', 'Device: Clear Care']}], 'interventions': [{'name': 'lotrafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['Air Optix Night & Day Aqua contact lenses'], 'description': 'FDA approved soft contact lenses', 'armGroupLabels': ['Clear Care solution and lotrafilcon A lenses', 'ReNu Multiplus and lotrafilcon A lenses']}, {'name': 'Renu Multiplus', 'type': 'DEVICE', 'armGroupLabels': ['ReNu Multiplus and lotrafilcon A lenses']}, {'name': 'Clear Care', 'type': 'DEVICE', 'armGroupLabels': ['Clear Care solution and lotrafilcon A lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Department of Ophthalmology University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Loretta Szczotka-Flynn, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'OD, PhD', 'investigatorFullName': 'Loretta Szczotka-Flynn', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}