Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
Study NCT ID:
NCT04498169
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2020-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015715', 'term': 'Corneal Edema'}, {'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msenchyna@aeriepharma.com', 'phone': '+1 908-947-3551', 'title': 'Michelle Senchyna, PhD. VP, Clinical Development and Medical Affairs.', 'organization': 'Aerie Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were documented from the time of signing the informed consent until the last study visit for each participant. This was a period of approximately 8 weeks (56 days) for participants who completed the full study duration. For AEs ongoing at the time of study completion, the ongoing AE was followed-up and the participant was provided appropriate medical care until the event resolved or stabilized, the participant was lost to follow-up, or there was other resolution to the event.', 'description': 'Adverse events information was collected at all study visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Once Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.\n\nNetarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Twice Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.\n\nNetarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 7, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Corneal verticillata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival hypaeremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Viral gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Central Corneal Thickness (CCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Once Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.\n\nNetarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution'}, {'id': 'OG001', 'title': 'Twice Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.\n\nNetarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.4', 'spread': '35.72', 'groupId': 'OG000'}, {'value': '-20.1', 'spread': '39.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The primary analysis used the mITT population with available data per subject at eye level (ie., ODO). Robustness analyses was also performed based on the MI methodology under different assumptions of missingness and intercurrent events (where missing data or withdrawal due to lack of efficacy or AEs were imputed using FCS regression method and missing data for all other reasons were imputed using worst within subject observation prior to the intercurrent event).', 'statisticalMethod': 'One-sample t-test (within group)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'With a sample size of up-to 20 subjects within a treatment group, the study had 80% power to demonstrate a statistically significant mean change from baseline, assuming the true effect size (mean change / SD) was 0.577 or larger (e.g. assuming the true mean change from baseline was 34.6 μm and the SD was 60 μm), a one sample t-test and a two-sided alpha = 0.10.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline & 4 weeks', 'description': 'Mean change from baseline in CCT by ultrasound pachymetry', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Once Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.\n\nNetarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution'}, {'id': 'FG001', 'title': 'Twice Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.\n\nNetarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution'}], 'periods': [{'title': 'Modified Intent-to-Treat Population', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Safety Population', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Per-Protocol Population', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Study Completion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment took place at 12 clinic sites in the United States between September 2020 and June 2021.', 'preAssignmentDetails': 'All participants underwent a washout of their pre-study treatment for Fuchs Corneal Dystrophy for a period of 24 hours prior to the baseline visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Once Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.\n\nNetarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution'}, {'id': 'BG001', 'title': 'Twice Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.\n\nNetarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution'}, {'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': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '40 participants were randomized; 20 each to the Netarsudil QD and the Netarsudil BID arms. 1 participant discontinued from each arm due to adverse events.\n\n40 participants were included in both the mITT population for the primary endpoint analysis and the safety population for safety analysis.\n\n6 participants were excluded from the per-protocol analysis due to protocol deviations (2 in the Netarsudil QD arm, 4 in the Netarsudil BID arm). There were no Covid-19 related protocol deviations.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-03', 'size': 740295, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-10T11:41', 'hasProtocol': True}, {'date': '2021-09-02', 'size': 989127, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-10T11:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2020-07-31', 'resultsFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2020-07-31', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-10', 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Corneal Thickness (CCT)', 'timeFrame': 'Baseline & 4 weeks', 'description': 'Mean change from baseline in CCT by ultrasound pachymetry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corneal Edema', 'Fuchs Corneal Dystrophy', 'Netarsudil Ophthalmic Solution'], 'conditions': ['Corneal Edema']}, 'referencesModule': {'references': [{'pmid': '36327101', 'type': 'DERIVED', 'citation': 'Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy. J Ocul Pharmacol Ther. 2022 Dec;38(10):657-663. doi: 10.1089/jop.2022.0069. Epub 2022 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 years or older\n2. Documented diagnosis of FCD\n3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)\n4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)\n\nExclusion Criteria:\n\n1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period\n2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation\n3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)'}, 'identificationModule': {'nctId': 'NCT04498169', 'acronym': 'Fuchs', 'briefTitle': 'A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aerie Pharmaceuticals'}, 'officialTitle': 'A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy', 'orgStudyIdInfo': {'id': 'AR-13324-CS210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Once Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.', 'interventionNames': ['Drug: Netarsudil Ophthalmic']}, {'type': 'EXPERIMENTAL', 'label': 'Twice Daily Netarsudil Ophthalmic Solution', 'description': 'One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.', 'interventionNames': ['Drug: Netarsudil Ophthalmic']}], 'interventions': [{'name': 'Netarsudil Ophthalmic', 'type': 'DRUG', 'otherNames': ['Rhopressa®'], 'description': 'Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution', 'armGroupLabels': ['Once Daily Netarsudil Ophthalmic Solution']}, {'name': 'Netarsudil Ophthalmic', 'type': 'DRUG', 'otherNames': ['Rhopressa®'], 'description': 'Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution', 'armGroupLabels': ['Twice Daily Netarsudil Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Ophthalmology', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Harvard Eye Associates', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '02748', 'city': 'South Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Advance Eye Associates', 'geoPoint': {'lat': 41.59177, 'lon': -70.94115}}, {'zip': '55420', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Chu Vision Institute', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '55305', 'city': 'Minnetonka', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Care', 'geoPoint': {'lat': 44.9133, 'lon': -93.50329}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '58078', 'city': 'West Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 46.87497, 'lon': -96.90036}}, {'zip': '43082', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Comprehensive Eye Care', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Eye Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Eye Consultants', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Michelle Senchyna, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aerie Pharmaceuticals Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aerie Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}