Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-02 @ 6:03 AM
Study NCT ID:
NCT04036292
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2019-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D059085', 'term': 'Nasal Sprays'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D000336', 'term': 'Aerosols'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jnau@oysterpointrx.com', 'phone': '609-382-9035', 'title': 'Jeffrey Nau', 'organization': 'Oyster Point Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 7', 'eventGroups': [{'id': 'EG000', 'title': 'OC-01 Low Dose, 0.6 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 253, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'OC-01 High Dose, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML', 'otherNumAtRisk': 245, 'deathsNumAtRisk': 245, 'otherNumAffected': 243, 'seriousNumAtRisk': 245, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo (vehicle) nasal spray', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 158, 'seriousNumAtRisk': 251, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pinguecula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival haemorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior capsule opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meibomian gland dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arcus lipoides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'corneal epithelium defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'corneal opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ectropion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid margin crusting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Glare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Keratopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trichiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual impairement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blepharal papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Melanocytic maevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 247}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 237}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 73}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal mucosal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal crusting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instillation site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronavirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arnold-Chiari malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01 Low Dose, 0.6 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML\n\nOC-01 (varenicline) nasal spray'}, {'id': 'OG001', 'title': 'OC-01 High Dose, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML\n\nOC-01 (varenicline) nasal spray'}, {'id': 'OG002', 'title': 'Placebo (Vehicle) Nasal Spray', 'description': 'Placebo (vehicle) nasal spray\n\nPlacebo (vehicle) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 Days [Visit 1 (baseline) and Visit 4b (28 days)]', 'description': "The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT-LOCF population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01 Low Dose, 0.6 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML'}, {'id': 'OG001', 'title': 'OC-01 High Dose, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (vehicle) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.3', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '-7.4', 'spread': '1.74', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 Days [Visit 1 (baseline) and Visit 4a (28 days)]', 'description': 'Change in Eye Dryness Score Eye from baseline in CAE at 4 Weeks at 5 minutes post treatment. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the mITT-2 population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01 Low Dose, 0.6 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML'}, {'id': 'OG001', 'title': 'OC-01 High Dose, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (vehicle) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.8', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-22.2', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '-15.4', 'spread': '1.57', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 Days [Visit 1 (baseline) and Visit 4b (28 days)]', 'description': 'Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT-LOCF population'}, {'type': 'SECONDARY', 'title': "Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28", 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01 Low Dose, 0.6 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML'}, {'id': 'OG001', 'title': 'OC-01 High Dose, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (vehicle) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '0.61', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 Days [Visit 1 (baseline) and Visit 4b (28 days)]', 'description': "Change in Schirmer test score from baseline to Day 28. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT-LOCF population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01 Low Dose, 0.6 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML'}, {'id': 'OG001', 'title': 'OC-01 High Dose, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (vehicle) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.5', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '-17.9', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '-12.7', 'spread': '1.41', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 Days [Visit 1 (baseline) and Visit 3 (14 days)]', 'description': 'Chang in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better otucome.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT-LOCF population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01 Low Dose, 0.6 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML'}, {'id': 'OG001', 'title': 'OC-01 High Dose, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (vehicle) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.7', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '-15.4', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '-13.3', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '7 Days [Visit 1 (baseline) and Visit 2 (7 days)]', 'description': 'Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OC-01 Low Dose 0.6 mg/mL BID for 28 Days', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML BID for 28 days'}, {'id': 'FG001', 'title': 'OC-01 High Dose 1.2 mg/mL BID for 28 Days', 'description': 'OC-01 (varenicline) nasal spray 1.2 mg/mL BID for 28 days'}, {'id': 'FG002', 'title': 'Placebo BID for 28 Days', 'description': 'Placebo (vehicle) nasal spray BID for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '246'}, {'groupId': 'FG002', 'numSubjects': '252'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '212'}, {'groupId': 'FG002', 'numSubjects': '228'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}, {'value': '758', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'OC-01 Low Dose 0.6 mg/mL BID for 28 Days', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML BID for 28 days\n\nOC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray'}, {'id': 'BG001', 'title': 'OC-01 High Dose 1.2 mg/mL BID for 28 Days', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML BID for 28 days\n\nOC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray'}, {'id': 'BG002', 'title': 'Placebo (Vehicle) Nasal Spray BID for 28 Days', 'description': 'Placebo (vehicle) nasal spray BID for 28 days\n\nPlacebo (vehicle) nasal spray: Placebo (vehicle) nasal spray'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '12.76', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '13.03', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '13.29', 'groupId': 'BG002'}, {'value': '58.8', 'spread': '13.02', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '576', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '658', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}, {'value': '630', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}, {'value': '758', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Baseline Schirmer's Test Score (mm)", 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '2.95', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '2.93', 'groupId': 'BG001'}, {'value': '4.9', 'spread': '2.89', 'groupId': 'BG002'}, {'value': '5.1', 'spread': '2.93', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.", 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Subjects in the ITT population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-18', 'size': 3537992, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-22T13:11', 'hasProtocol': True}, {'date': '2020-04-29', 'size': 6442638, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-22T13:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 758}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2019-07-25', 'resultsFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-22', 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)", 'timeFrame': '28 Days [Visit 1 (baseline) and Visit 4b (28 days)]', 'description': "The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome."}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes', 'timeFrame': '28 Days [Visit 1 (baseline) and Visit 4a (28 days)]', 'description': 'Change in Eye Dryness Score Eye from baseline in CAE at 4 Weeks at 5 minutes post treatment. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.'}, {'measure': 'Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28', 'timeFrame': '28 Days [Visit 1 (baseline) and Visit 4b (28 days)]', 'description': 'Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.'}, {'measure': "Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28", 'timeFrame': '28 Days [Visit 1 (baseline) and Visit 4b (28 days)]', 'description': "Change in Schirmer test score from baseline to Day 28. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome."}, {'measure': 'Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2', 'timeFrame': '14 Days [Visit 1 (baseline) and Visit 3 (14 days)]', 'description': 'Chang in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better otucome.'}, {'measure': 'Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1', 'timeFrame': '7 Days [Visit 1 (baseline) and Visit 2 (7 days)]', 'description': 'Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease (DED)']}, 'referencesModule': {'references': [{'pmid': '37096956', 'type': 'DERIVED', 'citation': 'Hauswirth SG, Kabat AG, Hemphill M, Somaiya K, Hendrix LH, Gibson AA. Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease. J Comp Eff Res. 2023 Jun;12(6):e220215. doi: 10.57264/cer-2022-0215. Epub 2023 Apr 25.'}, {'pmid': '36401081', 'type': 'DERIVED', 'citation': 'Nijm LM, Zhu D, Hemphill M, Blemker GL, Hendrix LH, Kabat AG, Gibson AA. Does Menopausal Status Affect Dry Eye Disease Treatment Outcomes with OC-01 (Varenicline Solution) Nasal Spray? A Post Hoc Analysis of ONSET-1 and ONSET-2 Clinical Trials. Ophthalmol Ther. 2023 Feb;12(1):355-364. doi: 10.1007/s40123-022-00607-7. Epub 2022 Nov 18.'}, {'pmid': '34767866', 'type': 'DERIVED', 'citation': 'Wirta D, Vollmer P, Paauw J, Chiu KH, Henry E, Striffler K, Nau J; ONSET-2 Study Group. Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The ONSET-2 Phase 3 Randomized Trial. Ophthalmology. 2022 Apr;129(4):379-387. doi: 10.1016/j.ophtha.2021.11.004. Epub 2021 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.', 'detailedDescription': "This was a Phase 3, multicenter, randomized, controlled, double-masked (including subjects, Investigators, study site personnel, and Sponsor personnel) study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray 0.6 mg/mL and 1.2 mg/mL in adult participants with DED. The study randomized 758 subjects at least 22 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria to receive OC-01 (varenicline) nasal spray or placebo twice daily (BID) for 28 days with three additional long-term follow-up visits at 6 weeks, 6 months, and 12 months. Participants who terminated from the study during the treatment period were asked to complete safety assessments (if the participants agree) prior to study exit. Participants who were terminated early from the study were not replaced"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1\n\nExclusion Criteria:\n\n* Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1.\n* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with dry eye disease are allowed.\n* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)\n* Have a known hypersensitivity to any of the procedural agents or study drug components\n* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.'}, 'identificationModule': {'nctId': 'NCT04036292', 'briefTitle': 'Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oyster Point Pharma, Inc.'}, 'officialTitle': 'Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)', 'orgStudyIdInfo': {'id': 'OPP-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OC-01 Low Dose, 0.6 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 0.6 mg/ML', 'interventionNames': ['Drug: OC-01 (varenicline) nasal spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OC-01 High Dose, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/ML', 'interventionNames': ['Drug: OC-01 (varenicline) nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (vehicle) nasal spray', 'description': 'Placebo (vehicle) nasal spray', 'interventionNames': ['Drug: Placebo (vehicle) nasal spray']}], 'interventions': [{'name': 'OC-01 (varenicline) nasal spray', 'type': 'DRUG', 'description': 'OC-01 (varenicline) nasal spray', 'armGroupLabels': ['OC-01 High Dose, 1.2 mg/mL', 'OC-01 Low Dose, 0.6 mg/mL']}, {'name': 'Placebo (vehicle) nasal spray', 'type': 'DRUG', 'description': 'Placebo (vehicle) nasal spray', 'armGroupLabels': ['Placebo (vehicle) nasal spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'New Port Beach', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United 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'facility': 'Sioux Falls', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37210', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Layton', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Lynchburg', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oyster Point Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}