Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-28 @ 4:55 AM
Study NCT ID:
NCT04806503
Status:
TERMINATED
Last Update Posted:
2024-06-20
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.', 'eventGroups': [{'id': 'EG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 26, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 22, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 16, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 23, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo ophthalmic solution; one drop twice-a-day for three months', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 21, 'seriousNumAtRisk': 46, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 108, 'seriousNumAtRisk': 234, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Central serous chorioretinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Corneal epithelium defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Episcleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eyelid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eyelid rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Eyelid skin dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Narrow anterior chamber angle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Noninfective conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dental cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 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0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 234, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL 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[{'pValue': '0.817', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.006', 'ciLowerLimit': '-0.045', 'ciUpperLimit': '0.056', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0258', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.946', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.002', 'ciLowerLimit': '-0.050', 'ciUpperLimit': '0.053', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0262', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.380', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.024', 'ciLowerLimit': '-0.077', 'ciUpperLimit': '0.029', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0270', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.667', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.011', 'ciLowerLimit': '-0.039', 'ciUpperLimit': '0.062', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0258', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG004', 'title': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.125', 'spread': '0.0217', 'groupId': 'OG000'}, {'value': '-0.121', 'spread': '0.0220', 'groupId': 'OG001'}, {'value': '-0.143', 'spread': '0.0241', 'groupId': 'OG002'}, {'value': '-0.112', 'spread': '0.0216', 'groupId': 'OG003'}, {'value': '-0.146', 'spread': '0.0228', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.474', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.022', 'ciLowerLimit': '-0.038', 'ciUpperLimit': '0.081', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0304', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.419', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.025', 'ciLowerLimit': '-0.036', 'ciUpperLimit': '0.086', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0309', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.914', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '0.003', 'ciLowerLimit': '-0.060', 'ciUpperLimit': '0.067', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0322', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.263', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.034', 'ciLowerLimit': '-0.026', 'ciUpperLimit': '0.094', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0305', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (worse-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40 cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG004', 'title': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.056', 'spread': '0.0194', 'groupId': 'OG000'}, {'value': '-0.075', 'spread': '0.0198', 'groupId': 'OG001'}, {'value': '-0.081', 'spread': '0.0210', 'groupId': 'OG002'}, {'value': '-0.059', 'spread': '0.0194', 'groupId': 'OG003'}, {'value': '-0.085', 'spread': '0.0206', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.284', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.029', 'ciLowerLimit': '-0.024', 'ciUpperLimit': '0.083', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0273', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.711', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.010', 'ciLowerLimit': '-0.044', 'ciUpperLimit': '0.065', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0278', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.871', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.005', 'ciLowerLimit': '-0.051', 'ciUpperLimit': '0.060', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0284', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}, {'pValue': '0.329', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.027', 'ciLowerLimit': '-0.027', 'ciUpperLimit': '0.080', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0273', 'statisticalMethod': 'Mixed-effect Model for Repeated Measures', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed-effect Model for Repeated Measures model-based two-sided t-test'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (better-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG004', 'title': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '10.30'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '17.90'}, {'value': '14.9', 'groupId': 'OG002', 'lowerLimit': '3.89', 'upperLimit': '25.92'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '11.70'}, {'value': '4.6', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '10.72'}]}]}], 'analyses': [{'pValue': '0.516', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.083', 'ciUpperLimit': '10.847', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.177', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.45', 'ciLowerLimit': '0.367', 'ciUpperLimit': '16.398', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.079', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.65', 'ciLowerLimit': '0.604', 'ciUpperLimit': '22.094', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.476', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.136', 'ciUpperLimit': '8.381', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': "Percentage of participants gaining at least 0.3 logMAR in binocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.\n\nPercentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG004', 'title': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '3.32', 'upperLimit': '22.62'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '17.33'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '17.82'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '1.31', 'upperLimit': '18.62'}, {'value': '11.9', 'groupId': 'OG004', 'lowerLimit': '2.16', 'upperLimit': '21.71'}]}]}], 'analyses': [{'pValue': '0.577', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.201', 'ciUpperLimit': '3.726', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.804', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.113', 'ciUpperLimit': '2.353', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.850', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.045', 'ciUpperLimit': '2.602', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.684', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.157', 'ciUpperLimit': '3.080', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': "Percentage of participants gaining at least 0.3 logMAR in monocular (worse-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.\n\nPercentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG004', 'title': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '13.20'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '17.93'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '2.50'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '7.88'}, {'value': '7.8', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '16.13'}]}]}], 'analyses': [{'pValue': '0.728', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.089', 'ciUpperLimit': '3.593', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.428', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.242', 'ciUpperLimit': '5.529', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.500', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '0.000', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'ciUpperLimitComment': 'NA when n = 1.', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}, {'pValue': '0.851', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.026', 'ciUpperLimit': '3.070', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Logistic model-based one-sided t-test'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3', 'description': "Percentage of participants gaining at least 0.3 logMAR in monocular (better-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.\n\nPercentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'POST_HOC', 'title': 'All Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'OG004', 'title': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months'}], 'classes': [{'title': 'Total Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'On-Treatment Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Post-Treatment Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On-treatment: up to 121 days, approx. 4 months. Off treatment: up to approx. 1 year and 1 month', 'description': 'On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication, for a maximum timeframe of approx. 4 months.\n\nPost-treatment deaths were collected from day 31 after last dose of study medication to end of study, up to approx. 1 year and 1 month.\n\nAll deaths refer to the sum of on-treatment and post-treatment deaths.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'FG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'FG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'FG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'FG004', 'title': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '234', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'BG001', 'title': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'BG002', 'title': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'BG003', 'title': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'BG004', 'title': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'spread': '2.61', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '2.80', 'groupId': 'BG001'}, {'value': '51.0', 'spread': '2.94', 'groupId': 'BG002'}, {'value': '50.5', 'spread': '2.66', 'groupId': 'BG003'}, {'value': '51.2', 'spread': '2.80', 'groupId': 'BG004'}, {'value': '50.9', 'spread': '2.75', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '135', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '166', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-03', 'size': 628185, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-14T16:11', 'hasProtocol': True}, {'date': '2022-11-23', 'size': 1068153, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-14T16:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'whyStopped': 'The study was discontinued by the Sponsor because it did not achieve the primary objective.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'dispFirstSubmitDate': '2023-05-01', 'completionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2021-03-16', 'resultsFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2021-03-16', 'dispFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-07', 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': 'Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.'}], 'secondaryOutcomes': [{'measure': 'Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': 'Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (worse-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40 cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.'}, {'measure': 'Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': 'Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (better-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.'}, {'measure': 'Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': "Percentage of participants gaining at least 0.3 logMAR in binocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.\n\nPercentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines."}, {'measure': 'Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': "Percentage of participants gaining at least 0.3 logMAR in monocular (worse-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.\n\nPercentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines."}, {'measure': 'Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': "Percentage of participants gaining at least 0.3 logMAR in monocular (better-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.\n\nPercentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['loss of elasticity in lens', 'lens', 'lens disorder', 'loss of near vision', 'Presbyopia', 'UNR844', 'farsightedness'], 'conditions': ['Presbyopia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1562', 'label': 'Patient Lay Trial Summary'}]}, 'descriptionModule': {'briefSummary': 'Study of safety and efficacy of UNR844 in subjects with presbyopia.', 'detailedDescription': 'This was a randomized, placebo-controlled, double-masked,multi-arm, parallel-group, multi-center 13-month study which consisted of:\n\n* A 1 week run-in period\n* A 3-month treatment course with UNR844 and/or Placebo\n* A 9-month treatment holiday period Participants were randomized equally to one of five treatment arms: UNR844 5 mg/mL,UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, or Placebo eye drops twice-a-day for three months.\n\nParticipants underwent a 1 week run-in period where they were assessed for entry criteria during the Screening visit. During the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. This run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (DCNVA) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. The run-in period was to help exclude participants with a change in DCNVA of 0.10 logMAR difference between Screening and Baseline.\n\nThis study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment is performed\n* Impaired near vision in each eye and when using both eyes, without any near correction\n* Need a certain level of near correction\n\nExclusion Criteria:\n\n* Impaired distance vision in either eye, with distance correction (if any)\n* Severe short- or long-sightedness\n* Any significant medical or clinical conditions affecting vision, the eyes or general health'}, 'identificationModule': {'nctId': 'NCT04806503', 'acronym': 'READER', 'briefTitle': 'A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia', 'orgStudyIdInfo': {'id': 'CUNR844A2202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UNR844 5 mg/mL', 'description': 'UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months', 'interventionNames': ['Drug: UNR844']}, {'type': 'EXPERIMENTAL', 'label': 'UNR844 13.3 mg/mL', 'description': 'UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months', 'interventionNames': ['Drug: UNR844']}, {'type': 'EXPERIMENTAL', 'label': 'UNR844 23 mg/mL', 'description': 'UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months', 'interventionNames': ['Drug: UNR844']}, {'type': 'EXPERIMENTAL', 'label': 'UNR844 30 mg/mL', 'description': 'UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months', 'interventionNames': ['Drug: UNR844']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Ophthalmic Solution', 'description': 'placebo ophthalmic solution; one drop twice-a-day for three months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'UNR844', 'type': 'DRUG', 'otherNames': ['EV06'], 'description': 'Ophthalmic solution for topical ocular administration', 'armGroupLabels': ['UNR844 13.3 mg/mL', 'UNR844 23 mg/mL', 'UNR844 30 mg/mL', 'UNR844 5 mg/mL']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Placebo', 'armGroupLabels': ['Placebo Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.61252, 'lon': 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States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37167', 'city': 'Smyrna', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.98284, 'lon': -86.5186}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': 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Investigative Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '565-0853', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '160-0008', 'city': 'Shinjuku Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/', 'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}