Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-01 @ 10:04 AM
Study NCT ID:
NCT03350620
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CHAMP: Study of NVK-002 in Children With Myopia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@vyluma.com', 'phone': '9083677400', 'title': 'VP of Clinical Development', 'organization': 'Vyluma, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years (Stage 1) and 1 year (Stage 2)', 'description': 'Treatment-emergent adverse events (TEAEs) are defined as any new or worsening of existing adverse events that occur or worsen between the first dose date of a specific stage and the last dose date of the same stage.\n\nAll-cause mortality, serious AE and other AE reporting are based on the Safety Set. The Safety Set (SS) will include all subjects who were administered at least one dose of study medication in Stage 1 or Stage 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: NVK-002 Concentration 1', 'description': 'Stage 1: Subjects randomized to NVK-002 Concentration 1\n\nNVK-002 Concentration 1: Study medication will be administered, once daily (QD)', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 56, 'seriousNumAtRisk': 164, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Stage 1: NVK-002 Concentration 2', 'description': 'Stage 1: Subjects randomized to NVK-002 Concentration 2\n\nNVK-002 Concentration 2: Study medication will be administered, once daily (QD)', 'otherNumAtRisk': 247, 'deathsNumAtRisk': 247, 'otherNumAffected': 92, 'seriousNumAtRisk': 247, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Stage 1: Vehicle (Placebo)', 'description': 'Stage 1: Subjects randomized to Vehicle (Placebo)\n\nPlacebo: Vehicle (placebo) will be administered, once daily (QD).\n\nNote: N=162 for the safety set (see comment in participant flow)', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 75, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Stage 2: NVK-002 Concentration 1', 'description': 'Stage 2: Subjects randomized to NVK-002 Concentration 1 include those from Stage 1 NVK-002 concentration, Stage 1 NVK-002 concentration 2 and Stage 1 Vehicle (Placebo).', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 43, 'seriousNumAtRisk': 159, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Stage 2: NVK-002 Concentration 2', 'description': 'Stage 2: Subjects randomized to NVK-002 Concentration 2 include those from Stage 1 NVK-002 concentration 1, NVK-002 concentration 2, and Stage 1 Vehicle (Placebo).', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 29, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Stage 2: Vehicle (Placebo)', 'description': 'Stage 2: Subjects randomized to Vehicle (Placebo) include those from Stage 1 NVK-002 concentration 1 and Stage 1 NVK-002 concentration 2.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 17, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ocular hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVIV-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Parainfluenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anal fisuure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'developmental hip dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'brain neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Disruptive mood dysregulation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}, {'units': "participants' eyes", 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}, {'value': '330', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NVK-002 Concentration 1', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 1\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.\n\nNVK-002 Concentration 1: Study medication will be administered, once daily (QD)'}, {'id': 'OG001', 'title': 'NVK-002 Concentration 2', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 2\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.\n\nNVK-002 Concentration 2: Study medication will be administered, once daily (QD)'}, {'id': 'OG002', 'title': 'Vehicle (Placebo)', 'description': 'Stage 1: Subjects will be randomized to Vehicle (Placebo)\n\nStage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms\n\nPlacebo: Vehicle (placebo) will be administered, once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 Months', 'description': "Number of subjects' eyes that show \\< 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit.", 'unitOfMeasure': "participants' eyes", 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': "participants' eyes", 'denomUnitsSelected': "participants' eyes", 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SER (Spherical Equivalent Refraction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}, {'units': "Participants' eyes", 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}, {'value': '330', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NVK-002 Concentration 1', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 1\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.\n\nNVK-002 Concentration 1: Study medication will be administered, once daily (QD)'}, {'id': 'OG001', 'title': 'NVK-002 Concentration 2', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 2\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.\n\nNVK-002 Concentration 2: Study medication will be administered, once daily (QD)'}, {'id': 'OG002', 'title': 'Vehicle (Placebo)', 'description': 'Stage 1: Subjects will be randomized to Vehicle (Placebo)\n\nStage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms\n\nPlacebo: Vehicle (placebo) will be administered, once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.85', 'groupId': 'OG000', 'lowerLimit': '-3.28', 'upperLimit': '1.22'}, {'value': '-1.02', 'groupId': 'OG001', 'lowerLimit': '-3.94', 'upperLimit': '0.89'}, {'value': '-1.10', 'groupId': 'OG002', 'lowerLimit': '-4.44', 'upperLimit': '3.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 36', 'description': 'Change from baseline in SER (spherical equivalent refraction).', 'unitOfMeasure': 'Diopter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': "Participants' eyes", 'denomUnitsSelected': "Participants' eyes", 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NVK-002 Concentration 1', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 1\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.\n\nNVK-002 Concentration 1: Study medication will be administered, once daily (QD)'}, {'id': 'FG001', 'title': 'NVK-002 Concentration 2', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 2\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.\n\nNVK-002 Concentration 2: Study medication will be administered, once daily (QD)'}, {'id': 'FG002', 'title': 'Vehicle (Placebo)', 'description': 'Stage 1: Subjects will be randomized to Vehicle (Placebo)\n\nStage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms\n\nPlacebo: Vehicle (placebo) will be administered, once daily (QD)'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '247'}, {'comment': '3 participants were assigned to placebo but did not take at least 1 dose of assigned treatment. hence N=165 for ITT in efficacy assessment and N=162 for the safety set used in TEAE reporting', 'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '22'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'comment': 'Per Statistical Analysis Plan, Stage 2 outcomes are all exploratory and tertiary outcomes.', 'achievements': [{'comment': 'Stage 2 concentration 1 is combined from 3 parallel groups: stage 1 placebo to stage 2 concentration 1 (N=62); stage 1 concentration 1 to stage 2 concentration 1 (N=38); stage 1 concentration 2 to stage 2 concentration 1 (N=59).', 'groupId': 'FG000', 'numSubjects': '159'}, {'comment': 'Stage 2 concentration 2 is combined from 3 parallel groups: stage 1 placebo to stage 2 concentration 2 (N=60); stage 1 concentration 1 to stage 2 concentration 2 (N=39); stage 1 concentration 2 to stage 2 concentration 2 (N=63).', 'groupId': 'FG001', 'numSubjects': '162'}, {'comment': 'Stage 2 Placebo is combined from 2 parallel groups: stage 1 concentration 1 to stage 2 Placebo (N=39); stage 1 concentration 2 to stage 2 Placebo (N=60).', 'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'unable to visit (1); used prohibited concomitant medication / withdrew consent (4); relocation (1).', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Enrolled subjects who did not meet the inclusion criteria or met the exclusion criteria were not randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '576', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'NVK-002 Concentration 1', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 1\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.\n\nNVK-002 Concentration 1: Study medication will be administered, once daily (QD)'}, {'id': 'BG001', 'title': 'NVK-002 Concentration 2', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 2\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.\n\nNVK-002 Concentration 2: Study medication will be administered, once daily (QD)'}, {'id': 'BG002', 'title': 'Vehicle (Placebo)', 'description': 'Stage 1: Subjects will be randomized to Vehicle (Placebo)\n\nStage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms\n\nPlacebo: Vehicle (placebo) will be administered, once daily (QD)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '8.9', 'spread': '2.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '315', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '261', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '309', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '465', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'SER', 'classes': [{'categories': [{'measurements': [{'value': '-2.25', 'groupId': 'BG000', 'lowerLimit': '-5.87', 'upperLimit': '-0.50'}, {'value': '-2.33', 'groupId': 'BG001', 'lowerLimit': '-5.87', 'upperLimit': '-0.50'}, {'value': '-2.41', 'groupId': 'BG002', 'lowerLimit': '-5.90', 'upperLimit': '-0.50'}, {'value': '-2.33', 'groupId': 'BG003', 'lowerLimit': '-5.90', 'upperLimit': '-0.50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Diopter', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-14', 'size': 231184, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-22T10:43', 'hasProtocol': True}, {'date': '2022-08-24', 'size': 2346905, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-03T14:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'If subjects meet eligibility criteria at the Screening/Baseline visit (Day 0), subjects will be randomly assigned to masked study medication.\n\nThe study will be double masked. The study medication will be provided in identical-appearing laminated pouches with no labeling indicating the identity of the study group or the contents of the ampules. The laminated pouches will contain identical-appearing ampules. Study subjects and study management personnel will be masked to the identity of treatment until after the final database lock.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages. Stage 1 is to assess the primary and secondary endpoints. Stage 2 is an extension stage for exploratory endpoints.\n\nStage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications.\n\nStage 2 is a randomized cross-over phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications with subjects initially randomized to Vehicle only eligible for randomization to low or high dose NVK-002.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 670}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2017-11-16', 'resultsFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-31', 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit", 'timeFrame': '36 Months', 'description': "Number of subjects' eyes that show \\< 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in SER (Spherical Equivalent Refraction)', 'timeFrame': 'Month 36', 'description': 'Change from baseline in SER (spherical equivalent refraction).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child, myopia, nearsightedness'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '37261839', 'type': 'DERIVED', 'citation': 'Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM, Lang E, Hemmati HD, Chandler SP; CHAMP Trial Group Investigators. Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression Over 3 Years: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Oct 1;141(10):990-999. doi: 10.1001/jamaophthalmol.2023.2097.'}]}, 'descriptionModule': {'briefSummary': 'Stage 1: To evaluate the safety and efficacy of 2 concentrations of NVK-002 compared to Vehicle (placebo) for slowing the progression of myopia in children over a 3 year treatment period.\n\nStage 2: To observe safety and efficacy in subjects re-randomized to one (1) year of treatment with NVK-002 or Vehicle following 3 years of treatment in children with progressive myopia.', 'detailedDescription': 'This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages.\n\nStage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications.\n\nStage 2 is a randomized follow-up phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to Vehicle only eligible for randomization to low or high-dose NVK-002.\n\nTreatment arms are:\n\n* NVK-002 low dose concentration\n* NVK-002 high dose concentration\n* Vehicle (placebo)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Children aged 3 to ≤ 17.0 years.\n2. Myopia SER of at least -0.50 D and no worse than -6.00 D myopia in each eye as measured by cycloplegic autorefraction.\n\nExclusion Criteria:\n\n1. If present, astigmatism more than -1.50 D in either eye.\n2. Current or history of amblyopia or strabismus.\n3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).\n4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).\n5. Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.\n6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication."}, 'identificationModule': {'nctId': 'NCT03350620', 'briefTitle': 'CHAMP: Study of NVK-002 in Children With Myopia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nevakar, Inc.'}, 'officialTitle': 'A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia', 'orgStudyIdInfo': {'id': 'CP-NVK002-0001'}, 'secondaryIdInfos': [{'id': '2018-001077-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVK-002 Concentration 1', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 1\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.', 'interventionNames': ['Drug: NVK-002 Concentration 1']}, {'type': 'EXPERIMENTAL', 'label': 'NVK-002 Concentration 2', 'description': 'Stage 1: Subjects will be randomized to NVK-002 Concentration 2\n\nStage 2: Subjects will be re-randomized to one of the three treatment arms.', 'interventionNames': ['Drug: NVK-002 Concentration 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle (Placebo)', 'description': 'Stage 1: Subjects will be randomized to Vehicle (Placebo)\n\nStage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NVK-002 Concentration 1', 'type': 'DRUG', 'otherNames': ['NVK-002 Conc 1'], 'description': 'Study medication will be administered, once daily (QD)', 'armGroupLabels': ['NVK-002 Concentration 1']}, {'name': 'NVK-002 Concentration 2', 'type': 'DRUG', 'otherNames': ['NVK-002 Conc 2'], 'description': 'Study medication will be administered, once daily (QD)', 'armGroupLabels': ['NVK-002 Concentration 2']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Vehicle (placebo) will be administered, once daily (QD)', 'armGroupLabels': ['Vehicle (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site #009', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94720', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Site #015', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Site #003', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92129', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Site #016', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Site #005', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Site #004', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site #024', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site #006', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Site #014', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Site #002', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27603', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Site #013', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site #001', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97116', 'city': 'Forest Grove', 'state': 'Oregon', 'country': 'United States', 'facility': 'Site #018', 'geoPoint': {'lat': 45.51984, 'lon': -123.11066}}, {'zip': '19027', 'city': 'Elkins Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site #011', 'geoPoint': {'lat': 40.07706, 'lon': -75.12684}}, {'zip': '17601', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site #017', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site #008', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site #007', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Site #012', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Site #020', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Site #021', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'H - 1085', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Site #104', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'D07 H6K8', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Site #101', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '3015 AA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Site # 105', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '8950', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Site #107', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'BT52 1HS', 'city': 'Coleraine', 'country': 'United Kingdom', 'facility': 'Site #103', 'geoPoint': {'lat': 55.13333, 'lon': -6.66667}}, {'zip': 'EC1V 2PD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Site #106', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Houman Hemmati, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nevakar, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vyluma, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}