Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT00553735
Status:
TERMINATED
Last Update Posted:
2017-03-28
First Post:
2007-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D065346', 'term': 'Lubricant Eye Drops'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D054327', 'term': 'Lubricants'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Cornea_Research@MEEI.Harvard.edu', 'phone': '617-573-3313', 'title': 'Reza Dana, MD, MPH, MSc', 'organization': 'Massachusetts Eye and Ear Infirmary'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to a high number of patients who withdrew themselves, failed to show for their appointments, or were lost to follow-up.'}}, 'adverseEventsModule': {'description': 'The adverse events reported are by "eye". Two adverse events were reported: uveitis and bacterial infection. Both these events were bilateral (i.e. both eyes), occurring in two separate subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I', 'description': 'The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Uveitis (bilateral)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial Infection (bilateral)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Corneal Staining Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A 0.05%', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}, {'id': 'OG001', 'title': 'Artificial Tear', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nArificial Tear: Artificial Tear - three times a day for 18 months.'}], 'timeFrame': '18 months', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.'}, {'type': 'PRIMARY', 'title': 'Conjunctival Staining Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A 0.05%', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}, {'id': 'OG001', 'title': 'Artificial Tear', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nArificial Tear: Artificial Tear - three times a day for 18 months.'}], 'timeFrame': '18 Months', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.'}, {'type': 'PRIMARY', 'title': 'Incidence and Severity of Ocular Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A 0.05%', 'description': 'The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}, {'id': 'OG001', 'title': 'Artificial Tear', 'description': 'The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nArtificial Tear three times a day for 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 Months', 'description': 'Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients enrolled in the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A 0.05%', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}, {'id': 'OG001', 'title': 'Artificial Tear', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nArificial Tear: Artificial Tear - three times a day for 18 months.'}], 'timeFrame': '18 Months', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Tear Break-up Time (TBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A 0.05%', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}, {'id': 'OG001', 'title': 'Artificial Tear', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nArificial Tear: Artificial Tear - three times a day for 18 months.'}], 'timeFrame': '18 Months', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Schirmer Without Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A 0.05%', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}, {'id': 'OG001', 'title': 'Artificial Tear', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nArificial Tear: Artificial Tear - three times a day for 18 months.'}], 'timeFrame': '18 Months', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Schirmer With Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A 0.05%', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}, {'id': 'OG001', 'title': 'Artificial Tear', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nArificial Tear: Artificial Tear - three times a day for 18 months.'}], 'timeFrame': '18 Months', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Each eye of every participant was randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I', 'description': 'The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.\n\nCyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'High number of withdrawals, appt. no-shows, or those lost to follow-up.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2007-11-02', 'resultsFirstSubmitDate': '2012-10-02', 'studyFirstSubmitQcDate': '2007-11-05', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-07', 'studyFirstPostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Staining Score', 'timeFrame': '18 months'}, {'measure': 'Conjunctival Staining Score', 'timeFrame': '18 Months'}, {'measure': 'Incidence and Severity of Ocular Adverse Event', 'timeFrame': '18 Months', 'description': 'Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.'}], 'secondaryOutcomes': [{'measure': 'Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire', 'timeFrame': '18 Months'}, {'measure': 'Tear Break-up Time (TBUT)', 'timeFrame': '18 Months'}, {'measure': 'Schirmer Without Anesthesia', 'timeFrame': '18 Months'}, {'measure': 'Schirmer With Anesthesia', 'timeFrame': '18 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Graft versus Host Disease', 'GVHD'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Restasis is an effective treatment for preventing the occurrence and progression of dry eye syndrome in patients who have recently received a bone marrow transplant and are at risk to graft-versus-host disease.', 'detailedDescription': 'The purpose of this research study is to determine if early treatment using Restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic bone marrow transplant (BMT) recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* At least 18 years of age\n* Approved candidate for allogeneic HSCT\n* Ability to understand and provide informed consent to participate in this study\n* Willingness to follow study instructions and likely to complete all required visits\n\nExclusion Criteria:\n\n* History of ocular or eyelid surgery\n* History of glaucoma or ocular hypertension\n* History of herpetic eye disease\n* Patient with acne rosacea, blepharitis, or meibomitis, in the opinion of the investigator\n* Any ocular disorder or condition (including ocular infection, trauma, and disease) that could possibly interfere with the interpretation of the study results\n* Recent (3-month) history of wearing contact lens\n* Anticipated contact lens wear during any portion of the study\n* Recent (3-month) history of current use of topical steroids or antiglaucoma agents\n* Any punctal occlusion within 2 months of the screening visit\n* Significant sign or symptoms of dry eye (the definition of "dry eye" used for exclusion criteria is compatible with the recommendations of the NEI/Industry Workshop on Clinical Trials in Dry Eyes (Lemp, 1995) (see Appendix 1and 2))\n* History of connective tissue disease or diabetes\n* Any condition (including language barrier) that precludes patient\'s ability to comply with study requirements including completion of study'}, 'identificationModule': {'nctId': 'NCT00553735', 'briefTitle': 'The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'The Prophylactic Use of Topical Cyclosporine A 0.05% (Restasis) to Prevent Onset and Progression of Graft-versus-host Disease-related Dry Eye', 'orgStudyIdInfo': {'id': '07-05-034'}, 'secondaryIdInfos': [{'id': '07-05-034', 'type': 'OTHER', 'domain': 'Massachusetts Eye and Ear'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporine A 0.05%', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.', 'interventionNames': ['Drug: Cyclosporine A 0.05%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Artificial Tear', 'description': 'If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)\n\nThe objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.', 'interventionNames': ['Drug: Arificial Tear']}], 'interventions': [{'name': 'Cyclosporine A 0.05%', 'type': 'DRUG', 'otherNames': ['Restasis'], 'description': 'Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.', 'armGroupLabels': ['Cyclosporine A 0.05%']}, {'name': 'Arificial Tear', 'type': 'DRUG', 'otherNames': ['Placebo', 'Artificial Tear'], 'description': 'Artificial Tear - three times a day for 18 months.', 'armGroupLabels': ['Artificial Tear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye and Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Reza Dana, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Eye and Ear Infirmary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts Eye and Ear Infirmary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}