Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-29 @ 1:53 AM
Study NCT ID:
NCT01393132
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2011-07-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gsosne@med.wayne.edu', 'phone': '248-594-6702', 'title': 'Gabriel Sosne, MD', 'organization': 'Wayne State Univeristy, Detroit, MI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '56 days', 'eventGroups': [{'id': 'EG000', 'title': 'Thymosin Beta 4', 'description': 'Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': ': A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thymosin', 'description': 'Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, Day 14, Day 28 and Day 56', 'description': 'Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).', 'unitOfMeasure': 'event', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Fluorescein Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thymosin', 'description': 'Comparison\n\nThymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Comparison\n\nThymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '3.406', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '4.927', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0108', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison of fluorescein staining score between the placebo and Thymosin beta 4 groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 56 (+28 day follow up)', 'description': 'Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up).\n\nThe scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Discomfort Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thymosin', 'description': 'Comparison\n\nThymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Comparison\n\nThymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.625', 'spread': '17.780', 'groupId': 'OG000'}, {'value': '67.233', 'spread': '15.658', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison of Ocular Discomfort Index score between the placebo and Thymosin beta 4 groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 56 (+28 day follow up)', 'description': 'Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup).\n\n(Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).\n\nThe OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision.\n\nFor every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time.\n\nOSDI scores are calculated according to: OSDI = \\[(sum of scores for all questions answered)\\*100\\] / \\[(total number of questions answered)\\*4\\].\n\nThe OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tear Film Break up Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thymosin', 'description': 'Comparison\n\nThymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Comparison\n\nThymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.550', 'spread': '2.302', 'groupId': 'OG000'}, {'value': '2.848', 'spread': '1.137', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0162', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison of Tear Film Break up Time between the placebo and Thymosin beta 4 groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 56 (+28 day follow up)', 'description': 'Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up).\n\nThe tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.\n\nRange : \\>10 seconds is thought to be normal, \\<5 seconds low (with high likelihood of dry eye symptoms).', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thymosin', 'description': 'Arm/Group \\* Reporting Groups Definition: Arms or comparison groups in a trial\n\nDescription Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.\n\nThymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.\n\nPeriod Title \\* Participant Flow: Overall Study\n\nPlacebo Thymosin Beta 4 Started 3 6 Completed 3 6'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Arm/Group \\* Reporting Groups Definition: Arms or comparison groups in a trial\n\nDescription Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment Details The study took place at Kresge Eye Institute by Dr. Gabriel Sosne, and at Michigan Cornea Consultants, P.C. by Dr. Steven P. Dunn,\n\nThe first subject was screened on Mar.2011 and the last subject last visit to the clinic was on Dec.2012', 'preAssignmentDetails': 'Pre-assignment Details:\n\nSubjects were evaluated upon entering the study after a two week washout period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Thymosin', 'description': 'Comparison\n\nThymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Comparison\n\nThymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '63.7', 'spread': '6.65', 'groupId': 'BG001'}, {'value': '57.33', 'spread': '11.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2011-07-07', 'resultsFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-21', 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Day 1, Day 14, Day 28 and Day 56', 'description': 'Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).'}], 'secondaryOutcomes': [{'measure': 'Corneal Fluorescein Staining', 'timeFrame': 'Days 56 (+28 day follow up)', 'description': 'Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up).\n\nThe scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability.'}, {'measure': 'Ocular Discomfort Index', 'timeFrame': 'Days 56 (+28 day follow up)', 'description': 'Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup).\n\n(Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).\n\nThe OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision.\n\nFor every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time.\n\nOSDI scores are calculated according to: OSDI = \\[(sum of scores for all questions answered)\\*100\\] / \\[(total number of questions answered)\\*4\\].\n\nThe OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.'}, {'measure': 'Tear Film Break up Time', 'timeFrame': 'Days 56 (+28 day follow up)', 'description': 'Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up).\n\nThe tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.\n\nRange : \\>10 seconds is thought to be normal, \\<5 seconds low (with high likelihood of dry eye symptoms).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye', "Sjogren's Syndrome", 'Graft vs. Host Disease', 'Rheumatoid arthritis', 'Systemic lupus erythematosus', 'Scleroderma'], 'conditions': ['Dry Eye', "Sjogren's Syndrome", 'Graft vs. Host Disease']}, 'referencesModule': {'references': [{'pmid': '25826322', 'type': 'DERIVED', 'citation': 'Sosne G, Dunn SP, Kim C. Thymosin beta4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. doi: 10.1097/ICO.0000000000000379.'}]}, 'descriptionModule': {'briefSummary': 'Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing.\n\nThe agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010).\n\nThe study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.', 'detailedDescription': 'See above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schirmers of \\< 5 mm at 5 minutes\n* TFBUT: less than 10 seconds\n* Corneal staining of \\>3 of 15: conjunctival staining of \\>3 of 18\n* Ocular Surface Disease Index of \\> 50\n* Presumed best corrected vision of 20/60 or better\n\nExclusion Criteria:\n\n* Acute or inflammatory corneal disease\n* Pregnancy or lactation\n* Monocular status\n* Punctal occlusion within 30 days\n* Ocular surgery within 3 months\n* Corneal thinning of \\>50%\n* Active corneal infection\n* History of ocular malignancy\n* Retinal neovascularization\n* Current use of topical cyclosporin A'}, 'identificationModule': {'nctId': 'NCT01393132', 'briefTitle': 'Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye', 'organization': {'class': 'OTHER', 'fullName': 'Michigan Cornea Consultants, PC'}, 'officialTitle': 'Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye', 'orgStudyIdInfo': {'id': '1003008179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thymosin Beta 4 eye drops', 'description': 'It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days', 'interventionNames': ['Drug: Thymosin Beta 4 eye drops']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Control', 'description': 'It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days.', 'interventionNames': ['Drug: Vehicle Control']}], 'interventions': [{'name': 'Thymosin Beta 4 eye drops', 'type': 'DRUG', 'otherNames': ['Tβ4'], 'description': 'Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.', 'armGroupLabels': ['Thymosin Beta 4 eye drops']}, {'name': 'Vehicle Control', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.', 'armGroupLabels': ['Vehicle Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Cornea Consultants, P.C.', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}], 'overallOfficials': [{'name': 'Steven P Dunn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan Cornea Consultants, P.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan Cornea Consultants, PC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kresge Eye Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Steven P. Dunn, M.D.', 'investigatorAffiliation': 'Michigan Cornea Consultants, PC'}}}}