Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:55 PM
Study NCT ID:
NCT05552261
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2022-09-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000647429', 'term': 'cenegermin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@dompe.com', 'phone': '+39 02 583831', 'title': 'Clinical Development & Operations', 'organization': 'Dompé Farmaceutici S.p.A.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For study participants enrolled in the NFG0120 study, the week 8 visit is the end of treatment visit and is to be considered as the baseline of the NGF0122 study. For the purpose of Adverse Events Reporting, the assessment period is from NGF0122 baseline (i.e., NGF0120 Week 8 / End of Treatment) till Month 30 of the NGF0122 study itself.', 'eventGroups': [{'id': 'EG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122) (all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 20, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Corneal dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neurotrophic keratopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Corneal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eyelid irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ocular rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Open angle glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Presbyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vitreous adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Amblyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Corneal deposits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Corneal infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Corneal scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Entropion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Trichiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Secretion discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Calcinosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Graft versus host disease in lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Graft versus host disease in skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthropod infestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transplant dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheterisation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vital dye staining cornea present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Overweight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': "Sjogren's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Visual field defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Migrane', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tonic clonic movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Idiopathic interstitial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stasis dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tobacco user', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transcatheter aortic valve implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number/Percentage of Patients Who Achieved Corneal Epithelial Healing at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) and Remained Healed at Month 24 and Month 30 of the NGF0122 Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Healed at NGF0120 Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Remained healed at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Remained healed at month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Corneal epithelial at Month 24 and Month 30 of the NGF0122 study was summarized as a binary goal attainment variable (Yes/No) based on the subset of patients who achieved corneal epithelial healing at Week 8 of the NGF0120, as determined by the Central Reading Center (CRC).\n\nHealing was defined as the absence of persistent epithelial staining abnormalities related to disease.\n\nThe persistence (or worsening) of a staining pattern in the same corneal area was considered a failure in terms of healing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'PRIMARY', 'title': 'Number/Percentage of Patients Who Did Not Achieve Corneal Epithelial Healing at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) Who Had a Healed Corneal Epithelium at Month 24 and 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Not healed at NGF0120 Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Healed at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Healed at month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Corneal epithelial healing at the overall Follow-up Month 24 and Month 30 was summarized as a binary goal attainment variable (Yes/No) based on the subset of patients who did not achieve corneal epithelial healing at Week 8 of the NGF0120, as determined by the Central Reading Center (CRC). Healing was defined as the absence of persistent epithelial staining abnormalities related to disease.\n\nEpithelial healing took into consideration the Baseline epithelial staining patterns of each patient and their evolution over time.The persistence (or worsening) of a staining pattern in the same corneal area was considered a failure in terms of healing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.\n\nPlease note that while at the Month 24 visit both patients had available data, at the month 30 only one of the two patients had available data.'}, {'type': 'SECONDARY', 'title': 'Number/Percentage of Patients With an Improvement in Corneal Sensitivity at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) Who Still Had Improvement in Corneal Sensitivity at Month 24 and 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Number of patients improved at Week 8 of the NGF0120 study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Still had improvement at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Still had improvement at month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Improvement in corneal sensitivity at the overall Follow-up Month 24 and 30 was assessed as a binary goal attainment variable (Yes/No), based on the subset of patients who achieved an improvement in corneal sensitivity at Week 8 of the NGF0120. Improvement was defined as a change from Baseline \\> 0 cm in the study eye. Corneal sensitivity was measured in the central National Eye Institute (NEI) zone using the Cochet-Bonnet aesthesiometer, before the instillation of any dilating or anesthetic drops. The filament was extended to its full length (6 cm), then retracted in 0.5 cm increments until the patient reported feeling contact. The filament length at which sensation was reported was recorded. Higher values indicate better sensitivity. Please note that patients without a Yes/No response available (=missing data) are not considered in the analysis. More in details, these missing patients are 4 at month 24 and 3 at month 30.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Number/Percentage of Patients Who Did Not Improved Corneal Sensitivity at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) and Improved Corneal Sensitivity at Month 24 and 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Number of patients not improved at Week 8 of the NGF0120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Had improvement at month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Had improvement at month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Improvement in corneal sensitivity at the overall Follow-up Month 24 and 30 was assessed as a binary goal attainment variable (Yes/No), based on the subset of patients who did not achieve an improvement in corneal sensitivity at Week 8 of the NGF0120. Improvement was defined as a change from Baseline \\> 0 cm in the study eye. Corneal sensitivity was measured using the Cochet-Bonnet aesthesiometer in the central NEI zone before the instillation of any anesthetic or dilating drops. The filament was extended to 6 cm and retracted in 0.5 cm increments until the patient reported sensation upon contact. Higher values indicate better sensitivity. Please note that patients without a Yes/No response available (=missing data) are not considered in the analysis. More in details, these missing patients are 1 at month 30 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Corneal Sensitivity From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Change from Baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '1.853', 'groupId': 'OG000'}]}]}, {'title': 'Change from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.69', 'spread': '1.953', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '1.743', 'groupId': 'OG000'}]}]}, {'title': 'Change from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.63', 'spread': '1.816', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Corneal sensitivity at the overall Follow-up Month 24 and Month 30 measured (in cm) in the qualifying NEI (National Eye Institute) zone of the study eye using the Cochet-Bonnet aesthesiometer before the instillation of any anesthetic or dilating drops.\n\nImprovement was defined as a change from Baseline \\> 0 cm in the study eye. Higher values indicate better sensitivity.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in Schirmer I Scores to Month 24 and Month 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '8.55', 'groupId': 'OG000'}]}]}, {'title': 'from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '9.13', 'groupId': 'OG000'}]}]}, {'title': 'from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '7.69', 'groupId': 'OG000'}]}]}, {'title': 'from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '5.35', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5158', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '1.2', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0670', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '-0.6', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6307', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '2.8', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0357', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '-0.6', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Change in Schirmer I test scores was assessed as a continuous outcome in the study eye from Baseline and at Week 8 of the NGF0120 to Month 24 and Month 30.\n\nThe Schirmer I test was conducted on unanesthetized eyes using standardized paper test strips placed in the lower temporal lid margin of each eye. After 5 minutes, the strip was removed, and the length of the moistened area (in millimeters) was recorded.This test measures aqueous tear production. Any change in mean score \\>0 was considered an improvement in dry eye. Higher scores indicate better tear production, while lower values are associated with more severe dry eye. A positive change from Baseline was interpreted as improvement.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in TFBUT to Months 24 and 30 of the NGF0122.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'From baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.695', 'spread': '2.2390', 'groupId': 'OG000'}]}]}, {'title': 'From week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.539', 'spread': '2.3275', 'groupId': 'OG000'}]}]}, {'title': 'From baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.384', 'spread': '2.0018', 'groupId': 'OG000'}]}]}, {'title': 'From week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.561', 'spread': '2.2242', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2836', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.695', 'ciLowerLimit': '-0.353', 'ciUpperLimit': '1.743', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5153', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.539', 'ciLowerLimit': '-0.550', 'ciUpperLimit': '1.628', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2530', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.384', 'ciLowerLimit': '-1.295', 'ciUpperLimit': '0.527', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3828', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.561', 'ciLowerLimit': '-1.574', 'ciUpperLimit': '0.451', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Change in Tear Film Break-Up Time was evaluated in the study eye. TFBUT was measured in seconds using fluorescein dye under cobalt blue illumination. After fluorescein instillation, the patient blinked once or twice, then kept the eye open; the time to first dry spot was recorded. Two values were averaged, or three if differing by \\>2 seconds. TFBUT values ranged from 0 seconds (tear film instability) to ≥10 seconds (normal stability). Values \\<5 seconds suggest clinically relevant tear film dysfunction. A positive change from Baseline or Week 8 (\\>0 seconds) was interpreted as improvement in tear film stability.', 'unitOfMeasure': 'sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Number/Percentage of Patients Who Achieved a 15-letter Improvement in BCDVA From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Achieved a 15-letter Gain from Baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Achieved a 15-letter Gain from Baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Achieved a 15-letter Gain from Week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Achieved a 15-letter Gain from Week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Best Corrected Distance Visual Acuity (BCDVA) at the overall Follow-up Month 24 and Month 30 was assessed in the study eye using the ETDRS visual acuity chart at a distance of 4 meters (13.1 feet), prior to any administration of anesthetic or mydriatic eye drops. Results were recorded as the number of letters correctly identified on the chart. This outcome evaluated the number and percentage of patients who gained at least 15 letters in BCDVA from DEFENDO Baseline and week 8, at Month 24 and Month 30. A gain of ≥15 letters is considered a clinically meaningful improvement corresponding to approximately three lines on the ETDRS chart. The endpoint was analyzed as a binary variable (Yes/No).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'From baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.1855', 'groupId': 'OG000'}]}]}, {'title': 'From week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.124', 'spread': '0.1097', 'groupId': 'OG000'}]}]}, {'title': 'From baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.056', 'spread': '0.1705', 'groupId': 'OG000'}]}]}, {'title': 'From week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.1440', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.7450', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.110', 'ciUpperLimit': '0.064', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.124', 'ciLowerLimit': '0.071', 'ciUpperLimit': '0.177', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1619', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.056', 'ciLowerLimit': '-0.134', 'ciUpperLimit': '0.021', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0100', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.087', 'ciLowerLimit': '0.020', 'ciUpperLimit': '0.154', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Best Corrected Distance Visual Acuity (BCDVA) at Month 24 and Month 30 was assessed in the study eye using the ETDRS visual acuity chart at 4 meters (13.1 feet), before any anesthetic or mydriatic eye drops or ocular procedures. Scores were recorded in logMAR units, ranging from -0.3 (better visual acuity) to 1.0 (poorer acuity). Higher logMAR values indicate worse vision. A negative change in logMAR (i.e., \\<0) indicated an improvement in visual acuity. Mean values and standard deviations were summarized descriptively at each timepoint.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120 = Baseline NGF0122) in Quality of Life (QoL) Expressed by the IDEEL to Months 24 and 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Daily activities - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '18.466', 'groupId': 'OG000'}]}]}, {'title': 'Daily activities - change from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '14.206', 'groupId': 'OG000'}]}]}, {'title': 'Daily activities - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.83', 'spread': '18.621', 'groupId': 'OG000'}]}]}, {'title': 'Daily activities - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.83', 'spread': '15.652', 'groupId': 'OG000'}]}]}, {'title': 'Emotional impact - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.50', 'spread': '19.130', 'groupId': 'OG000'}]}]}, {'title': 'Emotional impact - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.30', 'spread': '13.905', 'groupId': 'OG000'}]}]}, {'title': 'Emotional impact - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.93', 'spread': '19.710', 'groupId': 'OG000'}]}]}, {'title': 'Emotional impact - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.25', 'spread': '15.761', 'groupId': 'OG000'}]}]}, {'title': 'Impact on work - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.50', 'spread': '37.657', 'groupId': 'OG000'}]}]}, {'title': 'Impact on work - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.22', 'spread': '16.976', 'groupId': 'OG000'}]}]}, {'title': 'Impact on work - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.17', 'spread': '29.835', 'groupId': 'OG000'}]}]}, {'title': 'Impact on work - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.27', 'spread': '11.481', 'groupId': 'OG000'}]}]}, {'title': 'Treatment effectiveness - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.46', 'spread': '27.390', 'groupId': 'OG000'}]}]}, {'title': 'Treatment effectiveness - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '20.895', 'groupId': 'OG000'}]}]}, {'title': 'Treatment effectiveness - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.98', 'spread': '27.192', 'groupId': 'OG000'}]}]}, {'title': 'Treatment effectiveness - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.84', 'spread': '28.791', 'groupId': 'OG000'}]}]}, {'title': 'Treatment bother/inconvenience - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.23', 'spread': '24.756', 'groupId': 'OG000'}]}]}, {'title': 'Treatment bother/inconvenience - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.18', 'spread': '28.241', 'groupId': 'OG000'}]}]}, {'title': 'Treatment bother/inconvenience - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.54', 'spread': '19.243', 'groupId': 'OG000'}]}]}, {'title': 'Treatment bother/inconvenience - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.08', 'spread': '21.677', 'groupId': 'OG000'}]}]}, {'title': 'Dry eye symptom-bother - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.40', 'spread': '15.571', 'groupId': 'OG000'}]}]}, {'title': 'Dry eye symptom-bother - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '18.143', 'groupId': 'OG000'}]}]}, {'title': 'Dry eye symptom-bother - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.19', 'spread': '14.579', 'groupId': 'OG000'}]}]}, {'title': 'Dry eye symptom-bother - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '11.691', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': '"Impact of Dry Eye on Everyday Life" (IDEEL) is a 57-item questionnaire assessing dry eye impact (and consequently QoL), composed by 6 domains:\n\n* Daily Activities; Higher score = less impact\n* Emotional Impact: Higher score = less impact on emotions\n* Impact on Work: Higher score = less impact on work\n* Symptom Bother: Higher score = greater symptom bother\n* Treatment Bother: Higher score = less treatment-related bother\n* Treatment Effectiveness: Higher score = greater satisfaction with treatment effectiveness For 5 of 6 domains (Symptom Bother), higher scores on a 0-100 scale indicated improved quality of life relative to dry eye symptoms. For the domain of "symptom bother", a higher score indicated greater symptom bother. For this reason no total score, but only subscores, is calculated.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in Quality of Life Measured With EuroQol 5-Dimension 5-Level (EQ-5D-5L) to Months 24 and 30 of the NGF0122 Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Mobility - from Baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Mobility - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Mobility - from Baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Mobility - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.59', 'groupId': 'OG000'}]}]}, {'title': 'Self-Care - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'Self-Care - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Self-Care - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.65', 'groupId': 'OG000'}]}]}, {'title': 'Self-Care - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Usual Activities - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Usual Activities - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.55', 'groupId': 'OG000'}]}]}, {'title': 'Usual Activities - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Usual Activities - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Discomfort - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depression - from baseline to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depression - from week 8 to month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depression - from baseline to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Depression - from week 8 to month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'The EQ-5D-5L is a standardized questionnaire what measures the health status in 5 areas-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-with a rating scale of 1 (no problems) to 5 (extreme problems), where higher scores indicated worse problems.\n\nThe questionnaire also asks the patient to rate their current health ("how good or bad your health is today") on a scale from 0 (worst health you can imagine) to 100 (best health you can imagine). On a 0-100 scale, a higher "your health today" score indicated better health. The EQ-5D-5L questionnaire was self-administered by the patient before any ophthalmic procedures at either visit.\n\nPlease note that the severity level reported corresponds to the maximum experienced by the patient (for example, if a patient has one mild AE and one moderate AE, they are counted in the moderate category).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Number/Percentage of Subjects Reporting Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122) (all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study. No intervention was performed in this extension study.'}], 'classes': [{'title': 'number of patients reporting any AE', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting 0 AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting 1 AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting >1 AE', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting mild AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting moderate AEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting severe AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting AEs not related to any treatment administered', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting AEs related to any treatment administered', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Number (%) of Subjects Reporting any serious AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From NGF0120 Week 8=NGF0122 Baseline to Month 30 of the NGF0122 study', 'description': 'An AE was defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the medicinal (investigational) product, whether or not related to the study product.\n\nAEs by severity (categorized as mild, moderate and severe) and relatedness (categorized as related and not related ) are considered - per each single subject - just once, at the greater severity and closest relationship to treatment. Considering that no study IMP was administered and that all standard of care were permitted, AEs must be read as related to any standard of care administered during the FU study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}, {'type': 'SECONDARY', 'title': 'Frequency of Normal and Clinically Significant Abnormal Findings for Slit-lamp Examination Parameters in the Study Eye at Baseline and Week 8 of the NGF0120 and at Month 24 and 30 of the NGF0122', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'classes': [{'title': 'Lashes - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Lashes - Baseline -abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lashes - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Lashes - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lashes - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Lashes - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Lashes - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Lashes - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Edema - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Edema - Baseline -abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Edema - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Edema - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Edema - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Edema - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Edema - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Edema - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Erythema - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Erythema - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Erythema - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Erythema - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Erythema - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Erythema - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Erythema - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid Erythema - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Edema - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Edema - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Edema - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Edema - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Edema - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Edema - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Edema - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Edema - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Bulbar Erythema - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Bulbar Erythema - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Bulbar Erythema - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Bulbar Erythema - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Bulbar Erythema - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Bulbar Erythema - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Bulbar Erythema - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Conjunctiva Bulbar Erythema - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Epithelial Changes - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Epithelial Changes - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Epithelial Changes - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Epithelial Changes - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Epithelial Changes - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Epithelial Changes - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Epithelial Changes - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Epithelial Changes - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Endothelial Changes - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Endothelial Changes - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Endothelial Changes - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Endothelial Changes - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Endothelial Changes - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Endothelial Changes - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Endothelial Changes - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Corneal Endothelial Changes - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cornea Edema - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Cornea edema - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cornea Edema - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Cornea Edema - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cornea Edema - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Cornea Edema - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cornea edema - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Cornea Edema - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lens - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Lens - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lens - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lens - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lens - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lens - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Lens - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Lens - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Sclera - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Sclera - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sclera - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Sclera - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sclera - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Sclera - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sclera - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Sclera - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Iris - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Iris - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Iris - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Iris - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Iris - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Iris - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Iris - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Iris - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Cells - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Cells - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Cells - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Cells - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Cells - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Cells - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Cells - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Cells - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Flare - Baseline - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Flare - Baseline - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Flare - week 8 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Flare - week 8 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Flare - month 24 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Flare - month 24 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Flare - month 30 - normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Chamber Flare - month 30 - abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and week 8 of the NGF0120, month 24 and 30 of the NGF0122', 'description': 'Slit-lamp biomicroscopy was performed in the study eye at Baseline and Week 8 of the NGF0120 study, and at Month 24 and 30. The anterior segment was evaluated under magnification using standard slit-lamp illumination. Parameters included eyelid edema and erythema, lashes, conjunctiva edema and bulbar erythema, cornea edema, endothelial and epithelial changes, lens, sclera, iris, and anterior chamber cells and flare. Findings were assessed visually as normal, abnormal not clinically significant, or abnormal clinically significant, based on clinical judgment and standard ophthalmologic criteria. Only the participants reporting normal and abnormal clinically significant results are shown (along with the percentage vs the "Number Analyzed", for each timepoint) The number of participants with abnormal not clinically significant results can be derived as difference between the sum of the said two categories and the "Number Analyzed", per each parameter and timepoint', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study. The FAS was used for both efficacy and safety analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group Long-term Follow-up', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long- Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study. No intervention was performed in this extension study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'FAS Set', 'comment': 'The FAS (N=24) was the only analysis population in the extension study used for both efficacy and safety analyses. The FAS included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Failure to return to the study clinic within the allowed study window for the Month 30 visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Out of 37 patients enrolled in the original NGF0120 (DEFENDO) study, 24 patients chose to enroll in the long-term follow-up study (henceforth, "extension study", or "long-term follow-up study", NGF0122). All 24 patients had data available at the Month 24 visit, at the Month 30 visit, or both and were included in the FAS.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group Long-term Follow-up - FAS', 'description': 'All eligible patients in the original NGF0120 study, after completing enrollment, were invited to enter the Long-Term Follow-up Study (NGF0122)(all standard of care permitted), according to inclusion and exclusion criteria.\n\nThe NGF0122 study aim was to assess the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophtalmic solution administered in Stage 1 Neurotrophic Keratitis patients enrolled in the original NGF0120 study.\n\nNo intervention was performed in this extension study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '11.37', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'FAS population: The FAS (N=24) was the only analysis population in the extension study used for both efficacy and safety analyses. The FAS included all enrolled patients who attended either the Month 24 or Month 30 study visit or both in this extension study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-29', 'size': 7313320, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-31T10:36', 'hasProtocol': True}, {'date': '2024-03-22', 'size': 1564012, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-31T10:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2022-09-16', 'resultsFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-18', 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number/Percentage of Patients Who Achieved Corneal Epithelial Healing at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) and Remained Healed at Month 24 and Month 30 of the NGF0122 Study', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Corneal epithelial at Month 24 and Month 30 of the NGF0122 study was summarized as a binary goal attainment variable (Yes/No) based on the subset of patients who achieved corneal epithelial healing at Week 8 of the NGF0120, as determined by the Central Reading Center (CRC).\n\nHealing was defined as the absence of persistent epithelial staining abnormalities related to disease.\n\nThe persistence (or worsening) of a staining pattern in the same corneal area was considered a failure in terms of healing.'}, {'measure': 'Number/Percentage of Patients Who Did Not Achieve Corneal Epithelial Healing at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) Who Had a Healed Corneal Epithelium at Month 24 and 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Corneal epithelial healing at the overall Follow-up Month 24 and Month 30 was summarized as a binary goal attainment variable (Yes/No) based on the subset of patients who did not achieve corneal epithelial healing at Week 8 of the NGF0120, as determined by the Central Reading Center (CRC). Healing was defined as the absence of persistent epithelial staining abnormalities related to disease.\n\nEpithelial healing took into consideration the Baseline epithelial staining patterns of each patient and their evolution over time.The persistence (or worsening) of a staining pattern in the same corneal area was considered a failure in terms of healing.'}], 'secondaryOutcomes': [{'measure': 'Number/Percentage of Patients With an Improvement in Corneal Sensitivity at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) Who Still Had Improvement in Corneal Sensitivity at Month 24 and 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Improvement in corneal sensitivity at the overall Follow-up Month 24 and 30 was assessed as a binary goal attainment variable (Yes/No), based on the subset of patients who achieved an improvement in corneal sensitivity at Week 8 of the NGF0120. Improvement was defined as a change from Baseline \\> 0 cm in the study eye. Corneal sensitivity was measured in the central National Eye Institute (NEI) zone using the Cochet-Bonnet aesthesiometer, before the instillation of any dilating or anesthetic drops. The filament was extended to its full length (6 cm), then retracted in 0.5 cm increments until the patient reported feeling contact. The filament length at which sensation was reported was recorded. Higher values indicate better sensitivity. Please note that patients without a Yes/No response available (=missing data) are not considered in the analysis. More in details, these missing patients are 4 at month 24 and 3 at month 30.'}, {'measure': 'Number/Percentage of Patients Who Did Not Improved Corneal Sensitivity at NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) and Improved Corneal Sensitivity at Month 24 and 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Improvement in corneal sensitivity at the overall Follow-up Month 24 and 30 was assessed as a binary goal attainment variable (Yes/No), based on the subset of patients who did not achieve an improvement in corneal sensitivity at Week 8 of the NGF0120. Improvement was defined as a change from Baseline \\> 0 cm in the study eye. Corneal sensitivity was measured using the Cochet-Bonnet aesthesiometer in the central NEI zone before the instillation of any anesthetic or dilating drops. The filament was extended to 6 cm and retracted in 0.5 cm increments until the patient reported sensation upon contact. Higher values indicate better sensitivity. Please note that patients without a Yes/No response available (=missing data) are not considered in the analysis. More in details, these missing patients are 1 at month 30 only.'}, {'measure': 'Mean Change in Corneal Sensitivity From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Corneal sensitivity at the overall Follow-up Month 24 and Month 30 measured (in cm) in the qualifying NEI (National Eye Institute) zone of the study eye using the Cochet-Bonnet aesthesiometer before the instillation of any anesthetic or dilating drops.\n\nImprovement was defined as a change from Baseline \\> 0 cm in the study eye. Higher values indicate better sensitivity.'}, {'measure': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in Schirmer I Scores to Month 24 and Month 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Change in Schirmer I test scores was assessed as a continuous outcome in the study eye from Baseline and at Week 8 of the NGF0120 to Month 24 and Month 30.\n\nThe Schirmer I test was conducted on unanesthetized eyes using standardized paper test strips placed in the lower temporal lid margin of each eye. After 5 minutes, the strip was removed, and the length of the moistened area (in millimeters) was recorded.This test measures aqueous tear production. Any change in mean score \\>0 was considered an improvement in dry eye. Higher scores indicate better tear production, while lower values are associated with more severe dry eye. A positive change from Baseline was interpreted as improvement.'}, {'measure': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in TFBUT to Months 24 and 30 of the NGF0122.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Change in Tear Film Break-Up Time was evaluated in the study eye. TFBUT was measured in seconds using fluorescein dye under cobalt blue illumination. After fluorescein instillation, the patient blinked once or twice, then kept the eye open; the time to first dry spot was recorded. Two values were averaged, or three if differing by \\>2 seconds. TFBUT values ranged from 0 seconds (tear film instability) to ≥10 seconds (normal stability). Values \\<5 seconds suggest clinically relevant tear film dysfunction. A positive change from Baseline or Week 8 (\\>0 seconds) was interpreted as improvement in tear film stability.'}, {'measure': 'Number/Percentage of Patients Who Achieved a 15-letter Improvement in BCDVA From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Best Corrected Distance Visual Acuity (BCDVA) at the overall Follow-up Month 24 and Month 30 was assessed in the study eye using the ETDRS visual acuity chart at a distance of 4 meters (13.1 feet), prior to any administration of anesthetic or mydriatic eye drops. Results were recorded as the number of letters correctly identified on the chart. This outcome evaluated the number and percentage of patients who gained at least 15 letters in BCDVA from DEFENDO Baseline and week 8, at Month 24 and Month 30. A gain of ≥15 letters is considered a clinically meaningful improvement corresponding to approximately three lines on the ETDRS chart. The endpoint was analyzed as a binary variable (Yes/No).'}, {'measure': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) to Month 24 and Month 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'Best Corrected Distance Visual Acuity (BCDVA) at Month 24 and Month 30 was assessed in the study eye using the ETDRS visual acuity chart at 4 meters (13.1 feet), before any anesthetic or mydriatic eye drops or ocular procedures. Scores were recorded in logMAR units, ranging from -0.3 (better visual acuity) to 1.0 (poorer acuity). Higher logMAR values indicate worse vision. A negative change in logMAR (i.e., \\<0) indicated an improvement in visual acuity. Mean values and standard deviations were summarized descriptively at each timepoint.'}, {'measure': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120 = Baseline NGF0122) in Quality of Life (QoL) Expressed by the IDEEL to Months 24 and 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': '"Impact of Dry Eye on Everyday Life" (IDEEL) is a 57-item questionnaire assessing dry eye impact (and consequently QoL), composed by 6 domains:\n\n* Daily Activities; Higher score = less impact\n* Emotional Impact: Higher score = less impact on emotions\n* Impact on Work: Higher score = less impact on work\n* Symptom Bother: Higher score = greater symptom bother\n* Treatment Bother: Higher score = less treatment-related bother\n* Treatment Effectiveness: Higher score = greater satisfaction with treatment effectiveness For 5 of 6 domains (Symptom Bother), higher scores on a 0-100 scale indicated improved quality of life relative to dry eye symptoms. For the domain of "symptom bother", a higher score indicated greater symptom bother. For this reason no total score, but only subscores, is calculated.'}, {'measure': 'Change From NGF0120 Baseline and NGF0120 Week 8 (EoT NGF0120=Baseline NGF0122) in Quality of Life Measured With EuroQol 5-Dimension 5-Level (EQ-5D-5L) to Months 24 and 30 of the NGF0122 Study.', 'timeFrame': 'At Month 24 and Month 30 of the NGF0122 study', 'description': 'The EQ-5D-5L is a standardized questionnaire what measures the health status in 5 areas-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-with a rating scale of 1 (no problems) to 5 (extreme problems), where higher scores indicated worse problems.\n\nThe questionnaire also asks the patient to rate their current health ("how good or bad your health is today") on a scale from 0 (worst health you can imagine) to 100 (best health you can imagine). On a 0-100 scale, a higher "your health today" score indicated better health. The EQ-5D-5L questionnaire was self-administered by the patient before any ophthalmic procedures at either visit.\n\nPlease note that the severity level reported corresponds to the maximum experienced by the patient (for example, if a patient has one mild AE and one moderate AE, they are counted in the moderate category).'}, {'measure': 'Number/Percentage of Subjects Reporting Adverse Events (AEs)', 'timeFrame': 'From NGF0120 Week 8=NGF0122 Baseline to Month 30 of the NGF0122 study', 'description': 'An AE was defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the medicinal (investigational) product, whether or not related to the study product.\n\nAEs by severity (categorized as mild, moderate and severe) and relatedness (categorized as related and not related ) are considered - per each single subject - just once, at the greater severity and closest relationship to treatment. Considering that no study IMP was administered and that all standard of care were permitted, AEs must be read as related to any standard of care administered during the FU study.'}, {'measure': 'Frequency of Normal and Clinically Significant Abnormal Findings for Slit-lamp Examination Parameters in the Study Eye at Baseline and Week 8 of the NGF0120 and at Month 24 and 30 of the NGF0122', 'timeFrame': 'Baseline and week 8 of the NGF0120, month 24 and 30 of the NGF0122', 'description': 'Slit-lamp biomicroscopy was performed in the study eye at Baseline and Week 8 of the NGF0120 study, and at Month 24 and 30. The anterior segment was evaluated under magnification using standard slit-lamp illumination. Parameters included eyelid edema and erythema, lashes, conjunctiva edema and bulbar erythema, cornea edema, endothelial and epithelial changes, lens, sclera, iris, and anterior chamber cells and flare. Findings were assessed visually as normal, abnormal not clinically significant, or abnormal clinically significant, based on clinical judgment and standard ophthalmologic criteria. Only the participants reporting normal and abnormal clinically significant results are shown (along with the percentage vs the "Number Analyzed", for each timepoint) The number of participants with abnormal not clinically significant results can be derived as difference between the sum of the said two categories and the "Number Analyzed", per each parameter and timepoint'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stage 1 NK', 'OXERVATE®', 'Cenegermin', 'NK', 'DEFENDO', 'NGF0120 (original DEFENDO study)', 'NGF0122 (DEFENDO long-term follow-up study)'], 'conditions': ['Neurotrophic Keratitis']}, 'descriptionModule': {'briefSummary': 'Primary Objective\n\nTo evaluate the long-term safety and efficacy (healing) of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in Stage 1 neurotrophic keratitis (NK) patients who enrolled in the DEFENDO study.\n\nSecondary Objective\n\nTo evaluate the long-term efficacy of OXERVATE® 0.002% (20 mcg/mL) cenergemin-bkbj ophthalmic solution in terms of corneal sensitivity, Schirmer I test, tear film break-up time (TFBUT), best corrected distance visual acuity (BCDVA), and quality of life at 24 and 30 months post-treatment', 'detailedDescription': 'NGF0122 (DEFENDO Long-Term Follow-up) study was a Phase 4, multicenter, open label, long-term follow-up study evaluating safety and efficacy in the patients with Stage 1 Neurotrophic Keratitis (NK) who were enrolled in the NGF0120 (original DEFENDO) study and were treated with OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution for up to 8 weeks in the NGF0120.\n\nAfter completing enrollment in the NGF0120 Study, patients were invited to enter the NGF0122 Study (all standard of care permitted) in which two additional long-term follow-up visits occurred at 24- and 30-months post-treatment to evaluate long-term clinical outcomes.\n\nIn the NGF0122, study patients enrolled in the NFG0120 study were evaluated starting from week 8, which corresponds to the end of treatment of the NGF0120 study and is to be considered as the baseline of the NGF0122 study itself.\n\nPatients were treated per standard of care including additional OXERVATE® 0.002% if deemed appropriate by the Investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stage 1 NK', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Previously enrolled in the DEFENDO Study.\n2. Satisfied all Informed Consent requirements. The patient and/or their legal representative read, signed, and dated the IRB approved Informed Consent document before any study-related procedures were performed.\n3. Had the ability and willingness to comply with study procedures.\n\nExclusion Criteria:\n\nWere participating in another study that involved treating the study eye. Participation in non-ocular studies was acceptable provided that the treatment was not considered to be confounding with the DEFENDO Long-Term Follow-up Study, in the opinion of the Investigator.'}, 'identificationModule': {'nctId': 'NCT05552261', 'briefTitle': 'DEFENDO Long Term Follow-up Study in Stage 1 NK Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dompé Farmaceutici S.p.A'}, 'officialTitle': 'A Long-term Extension Study to Evaluate the Safety and Efficacy of OXERVATE® 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis Who Enrolled in the DEFENDO Study (NGF0120)', 'orgStudyIdInfo': {'id': 'NGF0122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group Long-term follow-up', 'description': 'All eligible patients, after completing enrollment in the original DEFENDO Study, were invited to enter the DEFENDO Long-Term Follow-Up Study (all standard of care permitted), according to inclusion and exclusion criteria.', 'interventionNames': ['Drug: Cenegemin in the DEFENDO Study']}], 'interventions': [{'name': 'Cenegemin in the DEFENDO Study', 'type': 'DRUG', 'otherNames': ['OXERVATE®'], 'description': 'Cenegemin as administered in the original DEFENDO Study. Long-term safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered in Stage 1 Neurotrophic Keratitis (NK) patients enrolled in the original DEFENDO Study (NGF0120 / NCT04485546).\n\nNo intervention was performed in this follow-up / extension study.', 'armGroupLabels': ['Group Long-term follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'New Vision Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '02011', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scheie Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Flavio Mantelli, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dompé'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dompé Farmaceutici S.p.A', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}