Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT01616056
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2012-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sjlee@fhcrc.org', 'phone': '206-667-6190', 'title': 'Stephanie J. Lee MD MPH', 'organization': 'FHCRC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 19, 'otherNumAffected': 14, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Foreign body sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swollen eye lids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excessive tearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal edema and stromal haze', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '75.4', 'spread': '4.25', 'groupId': 'OG000'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '63.2', 'spread': '4.82', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '61.8', 'spread': '4.52', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '56.3', 'spread': '7.28', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx\\_eye=mean(sx6,sx7,sx8)\\*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': '2 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': '8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '54.5', 'spread': '6.19', 'groupId': 'OG000'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '36.8', 'spread': '5.32', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '32.9', 'spread': '5.74', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '35.6', 'spread': '6.50', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': '2 weeks', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.11', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '5.00', 'spread': '0.56', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '4.37', 'spread': '0.45', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '3.94', 'spread': '0.59', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': '2 weeks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Safety of Bandage Contact Lenses at 1 month', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Comprehensive Ophthalmologic Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'logMAR visual acuity baseline', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.030', 'groupId': 'OG000'}]}]}, {'title': 'logMAR visual acuity 2 weeks', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.030', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'LogMAR visual acuity score of 0 is equivalent to 20/20 vision. Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Ophthalmology assessments made after 2 weeks were not analyzed because of incomplete data collection.'}, {'type': 'SECONDARY', 'title': 'Change in Optical Coherence Tomography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'timeFrame': '2 weeks', 'description': 'Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Optical coherence tomography results were not analyzed because of incomplete data collection.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2012-06-06', 'resultsFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-14', 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale', 'timeFrame': '3 months', 'description': 'Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx\\_eye=mean(sx6,sx7,sx8)\\*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.'}, {'measure': 'Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale', 'timeFrame': '3 months', 'description': '8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).'}, {'measure': 'Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index', 'timeFrame': '3 months', 'description': 'OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.'}, {'measure': 'Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI', 'timeFrame': '3 months', 'description': 'OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.'}, {'measure': 'Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale', 'timeFrame': '3 months', 'description': 'The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.'}, {'measure': 'Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale', 'timeFrame': '3 months', 'description': 'The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Who Experienced Serious Adverse Events', 'timeFrame': '1 month', 'description': 'Safety of Bandage Contact Lenses at 1 month'}, {'measure': 'Change in Comprehensive Ophthalmologic Evaluations', 'timeFrame': '2 weeks', 'description': 'LogMAR visual acuity score of 0 is equivalent to 20/20 vision. Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.'}, {'measure': 'Change in Optical Coherence Tomography', 'timeFrame': '2 weeks', 'description': 'Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic graft-versus-host disease', 'eye'], 'conditions': ['Graft Versus Host Disease', 'Ophthalmologic Complications']}, 'referencesModule': {'references': [{'pmid': '26189353', 'type': 'RESULT', 'citation': 'Inamoto Y, Sun YC, Flowers ME, Carpenter PA, Martin PJ, Li P, Wang R, Chai X, Storer BE, Shen TT, Lee SJ. Bandage Soft Contact Lenses for Ocular Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2015 Nov;21(11):2002-7. doi: 10.1016/j.bbmt.2015.07.013. Epub 2015 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the symptom improvement after 2 weeks of therapy with bandage lenses.\n\nSECONDARY OBJECTIVES:\n\nI. To confirm short-term safety within 1 month after bandage lenses.\n\nII. To determine improvement in ophthalmologic examinations after bandage lenses.\n\nIII. To explore the use of optical coherence tomography as an objective measure of corneal inflammation.\n\nOUTLINE:\n\nPatients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic graft versus host disease (GVHD) as defined by the National Institutes of Health (NIH) criteria\n* Ocular symptoms of NIH eye score 2 or greater:\n\n * Score 2: Moderate dry eye symptoms partially affecting activities of daily living (ADL) (requiring drops \\> 3 x per day or punctal plugs), WITHOUT vision impairment\n * Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by keratoconjunctivitis\n* No new systemic immunosuppressive medications within 1 month prior to enrollment\n* Subject has the ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Absolute neutrophil count \\< 1000/ul\n* Known hypersensitivity or allergy to contact lenses\n* Evidence of any active viral, bacterial, or fungal infection in the eyes that is progressive despite appropriate treatment\n* Treatment with contact lenses within the previous 3 months for any indication\n* Active psychiatric disorder, substance abuse or any other reason that would interfere with compliance with the study protocol'}, 'identificationModule': {'nctId': 'NCT01616056', 'briefTitle': 'Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation', 'orgStudyIdInfo': {'id': '2617.00'}, 'secondaryIdInfos': [{'id': 'NCI-2012-00862', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2617.00', 'type': 'OTHER', 'domain': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bandage Contact Lenses', 'description': 'Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: graft versus host disease prophylaxis/therapy', 'Other: questionnaire administration', 'Procedure: optical coherence tomography']}], 'interventions': [{'name': 'graft versus host disease prophylaxis/therapy', 'type': 'BIOLOGICAL', 'otherNames': ['prophylaxis/therapy, graft versus host disease', 'prophylaxis/therapy, GVHD'], 'description': 'Wear bandage lenses', 'armGroupLabels': ['Bandage Contact Lenses']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Bandage Contact Lenses']}, {'name': 'optical coherence tomography', 'type': 'PROCEDURE', 'description': 'Optional ancillary studies', 'armGroupLabels': ['Bandage Contact Lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Stephanie Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All data are available now for sharing. Researchers must contact Stephanie Lee and sign a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephanie Lee', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}