Viewing Study NCT02558400

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Ignite Creation Date: 2025-12-26 @ 12:17 PM
Ignite Modification Date: 2026-03-03 @ 10:05 AM
Study NCT ID: NCT02558400
Status: COMPLETED
Last Update Posted: 2019-06-04
First Post: 2015-09-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603944', 'term': 'netarsudil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'theah@aeriepharma.com', 'phone': '908-947-3844', 'title': 'Theresa GH Heah, MD, MBA', 'organization': 'Aerie Pharmaceuticals, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected during the course of the study of 12 month treatment and 2 month safety follow up.The safety population summarized subjects as-treated.', 'description': 'Safety population, defined as all randomized subjects who received at least 1 dose of investigational product.The safety population summarized subjects as-treated. 1 Subject was randomized to netarsudil but received latanoprost. Therefore, 1 less subject is in the netarsudil group and 1 additional subject is in the latanoprost group for the safety population. (applies to the numbers of subjects for SAEs, all cause mortality and other AEs sections)', 'eventGroups': [{'id': 'EG000', 'title': 'PG324 Ophthalmic Solution', 'description': 'PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)', 'otherNumAtRisk': 238, 'deathsNumAtRisk': 238, 'otherNumAffected': 169, 'seriousNumAtRisk': 238, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'AR-13324 Ophthalmic Solution 0.02%', 'description': 'Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 243, 'otherNumAffected': 160, 'seriousNumAtRisk': 243, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Latanoprost Ophthalmic Solution 0.005%', 'description': 'Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)', 'otherNumAtRisk': 237, 'deathsNumAtRisk': 237, 'otherNumAffected': 74, 'seriousNumAtRisk': 237, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Conjunctival Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 133, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 115, 'numAffected': 115}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 44, 'numAffected': 44}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cornea Verticillata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Conjunctival Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Punctate Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Instillation Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 52, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 55, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Bladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastric Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Intraductal Proliferative Breast Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ovarian Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Prostate Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Impaired Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Metabolic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Femoral Neck Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PG324 Ophthalmic Solution', 'description': 'PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'OG001', 'title': 'AR-13324 Ophthalmic Solution 0.02%', 'description': 'Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'OG002', 'title': 'Latanoprost Ophthalmic Solution 0.005%', 'description': 'Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}], 'classes': [{'title': 'Day 1, 0800 hours', 'categories': [{'measurements': [{'value': '24.84', 'spread': '3.316', 'groupId': 'OG000'}, {'value': '24.81', 'spread': '3.335', 'groupId': 'OG001'}, {'value': '24.59', 'spread': '2.914', 'groupId': 'OG002'}]}]}, {'title': 'Day 1, 1000 hours', 'categories': [{'measurements': [{'value': '23.72', 'spread': '3.587', 'groupId': 'OG000'}, {'value': '23.45', 'spread': '3.510', 'groupId': 'OG001'}, {'value': '23.43', 'spread': '3.385', 'groupId': 'OG002'}]}]}, {'title': 'Day 1, 1600 hours', 'categories': [{'measurements': [{'value': '22.59', 'spread': '3.610', 'groupId': 'OG000'}, {'value': '22.63', 'spread': '3.674', 'groupId': 'OG001'}, {'value': '23.43', 'spread': '3.370', 'groupId': 'OG002'}]}]}, {'title': 'Day 15, 0800 hours', 'categories': [{'measurements': [{'value': '15.68', 'spread': '3.532', 'groupId': 'OG000'}, {'value': '18.66', 'spread': '4.189', 'groupId': 'OG001'}, {'value': '17.74', 'spread': '3.467', 'groupId': 'OG002'}]}]}, {'title': 'Day 15, 1000 hours', 'categories': [{'measurements': [{'value': '14.93', 'spread': '3.417', 'groupId': 'OG000'}, {'value': '17.78', 'spread': '4.219', 'groupId': 'OG001'}, {'value': '17.36', 'spread': '3.548', 'groupId': 'OG002'}]}]}, {'title': 'Day 15, 1600 hours', 'categories': [{'measurements': [{'value': '14.83', 'spread': '2.978', 'groupId': 'OG000'}, {'value': '17.25', 'spread': '3.814', 'groupId': 'OG001'}, {'value': '17.11', 'spread': '3.236', 'groupId': 'OG002'}]}]}, {'title': 'Day 43, 0800 hours', 'categories': [{'measurements': [{'value': '16.04', 'spread': '3.268', 'groupId': 'OG000'}, {'value': '19.06', 'spread': '4.593', 'groupId': 'OG001'}, {'value': '17.58', 'spread': '3.465', 'groupId': 'OG002'}]}]}, {'title': 'Day 43, 1000 hours', 'categories': [{'measurements': [{'value': '15.39', 'spread': '3.175', 'groupId': 'OG000'}, {'value': '17.92', 'spread': '4.168', 'groupId': 'OG001'}, {'value': '17.06', 'spread': '3.250', 'groupId': 'OG002'}]}]}, {'title': 'Day 43, 1600 hours', 'categories': [{'measurements': [{'value': '15.43', 'spread': '3.065', 'groupId': 'OG000'}, {'value': '17.54', 'spread': '3.855', 'groupId': 'OG001'}, {'value': '16.97', 'spread': '3.240', 'groupId': 'OG002'}]}]}, {'title': 'Day 90, 0800 hours', 'categories': [{'measurements': [{'value': '16.37', 'spread': '3.377', 'groupId': 'OG000'}, {'value': '19.04', 'spread': '4.537', 'groupId': 'OG001'}, {'value': '17.53', 'spread': '3.280', 'groupId': 'OG002'}]}]}, {'title': 'Day 90, 1000 hours', 'categories': [{'measurements': [{'value': '15.41', 'spread': '3.038', 'groupId': 'OG000'}, {'value': '17.96', 'spread': '4.262', 'groupId': 'OG001'}, {'value': '16.88', 'spread': '3.139', 'groupId': 'OG002'}]}]}, {'title': 'Day 90, 1600 hours', 'categories': [{'measurements': [{'value': '15.49', 'spread': '3.126', 'groupId': 'OG000'}, {'value': '17.30', 'spread': '3.769', 'groupId': 'OG001'}, {'value': '16.67', 'spread': '3.115', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'PG324 vs. netarsudil', 'nonInferiorityComment': 'To claim superiority PG324 had to be statistically superior to netarsudil and to latanoprost at all 9 of 9 primary efficacy timepoints'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'PG324 vs. latanoprost'}], 'paramType': 'MEAN', 'timeFrame': 'Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)', 'description': 'The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Extent of Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PG324 Ophthalmic Solution 0.02%/0.005%', 'description': 'Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution\n\nPG324 Ophthalmic Solution 0.02%/0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'OG001', 'title': 'AR-13324 Ophthalmic Solution 0.02%', 'description': 'Netarsudil 0.02% ophthalmic solution\n\nNetarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'OG002', 'title': 'Latanoprost Ophthalmic Solution 0.005%', 'description': 'Latanoprost 0.005% ophthalmic solution\n\nLatanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}], 'classes': [{'categories': [{'measurements': [{'value': '275.7', 'spread': '129.94', 'groupId': 'OG000'}, {'value': '266.2', 'spread': '131.60', 'groupId': 'OG001'}, {'value': '330.4', 'spread': '89.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Exposure to study medication in days for all treatment groups', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population= all randomized subjects who received at least 1 dose of study medication. The safety population summarized subjects as-treated. 1 Subject was randomized to netarsudil but received latanoprost. Therefore, 1 less subject is in the netarsudil group and 1 additional subject is in the latanoprost group for the safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PG324 Ophthalmic Solution 0.02%/0.005%', 'description': 'PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'FG001', 'title': 'AR-13324 Ophthalmic Solution 0.02%', 'description': 'Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'FG002', 'title': 'Latanoprost Ophthalmic Solution 0.005%', 'description': 'Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '244'}, {'groupId': 'FG002', 'numSubjects': '236'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '203'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Non-Compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Disallowed Concurrent Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ineligible for the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}, {'value': '718', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PG324 Ophthalmic Solution', 'description': 'PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'BG001', 'title': 'AR-13324 Ophthalmic Solution 0.02%', 'description': 'Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'BG002', 'title': 'Latanoprost Ophthalmic Solution 0.005%', 'description': 'Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '407', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '11.33', 'groupId': 'BG000'}, {'value': '64.6', 'spread': '10.97', 'groupId': 'BG001'}, {'value': '65.4', 'spread': '10.98', 'groupId': 'BG002'}, {'value': '64.8', 'spread': '11.09', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '626', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '486', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-12', 'size': 5376447, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-11T12:52', 'hasProtocol': True}, {'date': '2016-07-20', 'size': 473323, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-11T12:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 718}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'dispFirstSubmitDate': '2018-04-12', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-13', 'studyFirstSubmitDate': '2015-09-16', 'dispFirstSubmitQcDate': '2018-04-12', 'resultsFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2015-09-23', 'dispFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-13', 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP)', 'timeFrame': 'Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)', 'description': 'The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.'}], 'secondaryOutcomes': [{'measure': 'Extent of Exposure', 'timeFrame': '12 months', 'description': 'Exposure to study medication in days for all treatment groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open-angle Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '32166538', 'type': 'DERIVED', 'citation': 'Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.\n\nFollowing completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age or older\n2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes\n3. Unmedicated intraocular pressure \\>20mmHg and \\<36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits\n4. Corrected visual acuity equivalent to 20/200 Snellen or better\n5. Able to give informed consent and follow study instructions\n\nExclusion Criteria:\n\n1. Clinically significant ocular disease\n2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles\n3. Unmedicated Intraocular pressure ≥36mmHg\n4. Use of more than 2 ocular hypotensive medications within 30 days of screening\n5. Known hypersensitivity to any component of the formulation\n6. Previous glaucoma surgery or refractive surgery\n7. Ocular trauma within 6 months prior to screening\n8. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening\n9. Recent or current ocular infection or inflammation in either eye\n10. Used ocular medication in either eye of any kind within 30 days of screening\n11. Mean central corneal thickness \\>620µm at screening\n12. Any abnormality preventing reliable applanation tonometry of either eye\n13. Clinically significant abnormalities in lab tests at screening\n14. Clinically significant systemic disease\n15. Participation in any investigational study within 60 days prior to screening\n16. Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening\n17. Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control'}, 'identificationModule': {'nctId': 'NCT02558400', 'briefTitle': 'Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aerie Pharmaceuticals'}, 'officialTitle': 'A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects With Elevated Intraocular Pressure', 'orgStudyIdInfo': {'id': 'PG324-CS301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PG324 Ophthalmic Solution 0.02%/0.005%', 'description': 'Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution', 'interventionNames': ['Drug: PG324 Ophthalmic Solution 0.02%/0.005%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AR-13324 Ophthalmic Solution 0.02%', 'description': 'Netarsudil 0.02% ophthalmic solution', 'interventionNames': ['Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Latanoprost Ophthalmic Solution 0.005%', 'description': 'Latanoprost 0.005% ophthalmic solution', 'interventionNames': ['Drug: Latanoprost Ophthalmic Solution 0.005%']}], 'interventions': [{'name': 'PG324 Ophthalmic Solution 0.02%/0.005%', 'type': 'DRUG', 'description': '1 drop once daily (QD), in the evening (PM) in both eyes (OU)', 'armGroupLabels': ['PG324 Ophthalmic Solution 0.02%/0.005%']}, {'name': 'Netarsudil (AR-13324) Ophthalmic Solution 0.02%', 'type': 'DRUG', 'description': '1 drop once daily (QD), in the evening (PM) in both eyes (OU)', 'armGroupLabels': ['AR-13324 Ophthalmic Solution 0.02%']}, {'name': 'Latanoprost Ophthalmic Solution 0.005%', 'type': 'DRUG', 'description': '1 drop once daily (QD), in the evening (PM) in both eyes (OU)', 'armGroupLabels': ['Latanoprost Ophthalmic Solution 0.005%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07921', 'city': 'Bedminster', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Aerie Pharmaceuticals', 'geoPoint': {'lat': 40.68066, 'lon': -74.64544}}], 'overallOfficials': [{'name': 'Theresa Heah, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aerie Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aerie Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}