Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00727402
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2008-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Longitudinal Evaluation of Silicone Hydrogel (LASH) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'loretta.szczotka@uhhospitals.org', 'phone': '216-844-3609', 'title': 'Loretta Szczotka-Flynn OD, PhD', 'organization': 'Case Western Reserve University Dept Ophthalmology & Visual Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Observational', 'description': 'healthy patients fit into lotrafilcon A contact lenses for continuous wear', 'otherNumAtRisk': 205, 'otherNumAffected': 58, 'seriousNumAtRisk': 205, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'corneal inflammatory event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 44, 'numAffected': 38}], 'organSystem': 'Eye disorders'}, {'term': 'Other non-Corneal Inflammatory Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 20}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Incidence of Corneal Inflammatory Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '410', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational', 'description': 'healthy patients fit into lotrafilcon A contact lenses for continuous wear'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '35.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'annual', 'description': 'Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.', 'unitOfMeasure': 'annual incidence per 100 subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Observational', 'description': 'healthy patients fit into lotrafilcon A contact lenses for continuous wear'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '116'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Observational', 'description': 'healthy patients fit into lotrafilcon A contact lenses for continuous wear'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<=21 years', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Between 21 and 50 years', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}, {'title': '>50 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '157', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'tear samples contact lenses bacteria isolated from contact lenses'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-13', 'studyFirstSubmitDate': '2008-07-31', 'resultsFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2008-07-31', 'lastUpdatePostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-14', 'studyFirstPostDateStruct': {'date': '2008-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Incidence of Corneal Inflammatory Events', 'timeFrame': 'annual', 'description': 'Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Corneal Infiltrates']}, 'referencesModule': {'references': [{'pmid': '20538985', 'type': 'RESULT', 'citation': 'Szczotka-Flynn L, Lass JH, Sethi A, Debanne S, Benetz BA, Albright M, Gillespie B, Kuo J, Jacobs MR, Rimm A. Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5421-30. doi: 10.1167/iovs.10-5456. Epub 2010 Jun 10.'}, {'pmid': '19786927', 'type': 'RESULT', 'citation': 'Szczotka-Flynn LB, Bajaksouzian S, Jacobs MR, Rimm A. Risk factors for contact lens bacterial contamination during continuous wear. Optom Vis Sci. 2009 Nov;86(11):1216-26. doi: 10.1097/OPX.0b013e3181bbca18.'}, {'pmid': '21173699', 'type': 'RESULT', 'citation': 'Szczotka-Flynn L, Benetz BA, Lass J, Albright M, Gillespie B, Kuo J, Fonn D, Sethi A, Rimm A. The association between mucin balls and corneal infiltrative events during extended contact lens wear. Cornea. 2011 May;30(5):535-42. doi: 10.1097/ICO.0b013e3181fb8644.'}, {'pmid': '24681609', 'type': 'DERIVED', 'citation': 'Tagliaferri A, Love TE, Szczotka-Flynn LB. Risk factors for contact lens-induced papillary conjunctivitis associated with silicone hydrogel contact lens wear. Eye Contact Lens. 2014 May;40(3):117-22. doi: 10.1097/ICL.0000000000000019.'}]}, 'descriptionModule': {'briefSummary': 'The LASH Contact Lens Study is a prospective longitudinal study of silicone hydrogel (SH) contact lens wearers who sleep in their lenses for up to 29 consecutive nights (30 days) of continuous wear (CW), with monthly disposal. Up to 207 healthy nearsighted or farsighted patients with minimal or no astigmatism and no contraindications to CW lens use will be followed for 1 year. The primary outcome measure is the time to development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is corneal staining. Other key exploratory variables include bacterial contamination of study lenses and inflammatory mediators found in the tear film.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'study volunteers from academic community willing to wear extended wear contact lenses', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient must be at least 15 years old. Children younger than this may not be mature enough for CW, and may have difficulty following the strict instructions required for CW or sitting through the exam procedures.\n2. The patient must have clear central corneas and 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. The parameters of the Ciba Vision Night and Day Lenses range from +6.00 to -10.00 D, and can correct the refractive range of this population. Monovision correction will be allowed only if the near eye does not exceed +6.00 D.\n4. The patient must be correctable to 20/25 or better with spectacles. Amblyopia will be excluded.\n5. Flat and steep corneal curvatures from SimK readings must be between 39.00 and 48.00 D. Corneal curvatures outside this range may be indicative of a disease state, and patients are not expected to comfortably wear either the 8.4 mm or 8.6 mm base curve available in Night and Day.(Dumbleton K 2002)\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 PMMA lenses within the last 3 months. These lenses can transiently alter the corneal shape and influence the fitting of soft lenses.\n2. The patient must not be a current extended wear user of lotrafilcon A lenses.\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.\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.\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 CW.\n8. The patient is pregnant."}, 'identificationModule': {'nctId': 'NCT00727402', 'acronym': 'LASH', 'briefTitle': 'Longitudinal Evaluation of Silicone Hydrogel (LASH) Study', 'organization': {'class': 'NIH', 'fullName': 'National Eye Institute (NEI)'}, 'officialTitle': 'The Longitudinal Evaluation of Silicone Hydrogel (LASH) Contact Lens Study', 'orgStudyIdInfo': {'id': 'K23EY015270-01', 'link': 'https://reporter.nih.gov/quickSearch/K23EY015270-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'healthy patients fit into lotrafilcon A contact lenses for continuous wear'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Loretta B Szczotka-Flynn, OD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Loretta Szczotka-Flynn', 'investigatorAffiliation': 'Case Western Reserve University'}}}}