Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-06-26 @ 7:29 AM
Study NCT ID:
NCT03982368
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000647429', 'term': 'cenegermin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@dompe.com', 'phone': '+39 02 583831', 'title': 'Clinical Development & Operations', 'organization': 'Dompé farmaceutici s.p.a.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From Screening day to week 16', 'description': 'More specifically, adverse events are assessed at Screening day, Visit 1 Day 1), Visit 2 (Day 14), Visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84), Visit 6 (Day 112).', 'eventGroups': [{'id': 'EG000', 'title': 'rhNGF 20 μg/ml TID - Treatment Period', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 65, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD - Treatment Period', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 60, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vehicle TID - Treatment Period', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 26, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'rhNGF 20 μg/ml TID - Follow-up Period', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 19, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD - Follow-up Period', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 19, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Vehicle TID - Follow up Period', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 18, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctival Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctival Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctival Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Erythema Of Eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 68, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 73, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eyelid Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eyelid Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eyelid Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eyelid Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Foreign Body Sensation In Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Meibomian Gland Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ocular Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Posterior Capsule Opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Schirmer I Test (Without Anesthesia) vs Week 4 - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.60', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '1.68', 'spread': '0.75', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.078', 'groupIds': ['OG000', 'OG002'], 'paramType': 'least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '3.32', 'groupDescription': "The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.066', 'groupIds': ['OG001', 'OG002'], 'paramType': 'least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.31', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '4.70', 'groupDescription': "The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'The Schirmer test is used in ophthalmic examination to measure tear production for the diagnosis of conditions such as keratoconjunctivitis sicca and dry eye.\n\nWithout previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.\n\nThe patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)\n\nCutoff values:\n\n\\<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \\>10 and \\<30 mm - normal secretion', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Schirmer I Test (Without Anesthesia) vs Week 4 - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.99', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '1.28', 'spread': '0.74', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '4.12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.029', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.44', 'ciLowerLimit': '0.02', 'ciUpperLimit': '4.86', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'The Schirmer test is used in ophthalmic examination to measure tear production for the diagnosis of conditions such as keratoconjunctivitis sicca and dry eye.\n\nWithout previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.\n\nThe patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)\n\nCutoff values:\n\n\\<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \\>10 and \\<30 mm - normal secretion', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Severity vs Week 4 - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.6', 'spread': '27.15', 'groupId': 'OG000'}, {'value': '-20.3', 'spread': '24.91', 'groupId': 'OG001'}, {'value': '-22.2', 'spread': '22.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.534', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.611', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The global score is calculated by taking the square root of the product of the severity of symptoms per the frequency of symptoms. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Severity vs Week 4 - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.9', 'spread': '27.35', 'groupId': 'OG000'}, {'value': '-19.9', 'spread': '25.34', 'groupId': 'OG001'}, {'value': '-22.1', 'spread': '21.74', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.486', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.564', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The global score is calculated by taking the square root of the product of the severity of symptoms per the frequency of symptoms. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Frequency vs Week 4 - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.9', 'spread': '26.29', 'groupId': 'OG000'}, {'value': '-22.7', 'spread': '25.42', 'groupId': 'OG001'}, {'value': '-24.0', 'spread': '23.81', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome.The SANDE global score is calculated by taking the square root of the product of the frequency of symptoms and the severity of symptoms. The SANDE scale ranges from 0 to 100 wi.100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Frequency vs Week 4 - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.7', 'spread': '26.73', 'groupId': 'OG000'}, {'value': '-22.2', 'spread': '25.67', 'groupId': 'OG001'}, {'value': '-23.8', 'spread': '23.92', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.810', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.733', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score. The SANDE scale ranges from 0 to 100 wi.100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Schirmer II Test (With Anesthesia) vs Week 4 - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.68', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '4.13', 'groupDescription': "The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.243', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '2.83', 'groupDescription': "The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'The Schirmer II test is performed as the Schirmer I test after instilling anesthetic drops. The Schirmer strips are inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. All patients are seated at rest with their eyes closed, and the lower cul-de-sac is gently dried with a cotton applicator before the placement of strips.\n\nCut-off values:\n\n\\<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \\>10 and \\<30 mm - normal secretion', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Schirmer II Test (With Anesthesia) vs Week 4 - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.24', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.41', 'ciLowerLimit': '0.28', 'ciUpperLimit': '4.54', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.230', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '2.85', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'The Schirmer II test is performed as the Schirmer I test after instilling anesthetic drops. The Schirmer strips are inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.\n\nAll patients are seated at rest with their eyes closed, and the lower cul-de-sac is gently dried with a cotton applicator before the placement of strips.\n\nCut-off values:\n\n\\<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \\>10 and \\<30 mm - normal secretion', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Corneal and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) vs Week 4 - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'title': 'corneal and conjunctival total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.75', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '-2.60', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'corneal score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.72', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '2.92', 'groupId': 'OG002'}]}]}, {'title': 'conjunctiva score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '3.58', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '3.36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.799', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-3.11', 'ciUpperLimit': '0.80', 'groupDescription': "The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.\n\np value for total corneal ancd conjunctival score is reported.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Last Observation Carried Forward (LOCF) was used for imputing missing data in the Full analysis set at Week 4.'}, {'pValue': '0.715', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '1.59', 'groupDescription': "The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'Corneal staining total score is defined as the sum of scores from 5 corneal areas: Central, Superior, Temporal, Nasal, and Inferior. The score for each area ranges from 0 to 3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage. Thus, the corneal staining total score can range from 0 to 15 where the higher the score the worse is the outcome.\n\nThe conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage and with a maximal score of 9 for the nasal and temporal conjunctiva. Thus, the conjunctival staining total score can range from 0 to 18 where the higher the score the worse is the outcome.\n\nCorneal and conjunctiva vital staining total score is the sum of corneal staining total score and conjunctiva total score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Corneal and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) vs Week 4 - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'title': 'Total score', 'categories': [{'measurements': [{'value': '-3.94', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-2.61', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '-2.40', 'spread': '0.57', 'groupId': 'OG002'}]}]}, {'title': 'Corneal score', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.61', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '2.85', 'groupId': 'OG002'}]}]}, {'title': 'Conjunctival score', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.05', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '3.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.831', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.54', 'ciLowerLimit': '-3.40', 'ciUpperLimit': '0.31', 'groupDescription': "The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.\n\np value for total corneal ancd conjunctival score is reported.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.750', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '1.66', 'groupDescription': "The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.\n\np value for total corneal ancd conjunctival score is reported.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'Corneal staining total score is defined as the sum of scores from 5 corneal areas: Central, Superior, Temporal, Nasal, and Inferior. The score for each area ranges from 0 to 3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage. Thus, the corneal staining total score can range from 0 to 15 where the higher the score the worse is the outcome.\n\nThe conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage and with a maximal score of 9 for the nasal and temporal conjunctiva. Thus, the conjunctival staining total score can range from 0 to 18 where the higher the score the worse is the outcome.\n\nCorneal and conjunctiva vital staining total score is the sum of corneal staining total score and conjunctiva total score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results. This analysis set was used for supportive efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Film Break-Up Time (TFBUT) vs Week 4 - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.17', 'ciUpperLimit': '1.75', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.217', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '1.07', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'Tear film break-up time (TFBUT) is the time taken to appear first dry spot on cornea after a complete blinking. TFBUT measurement is an easy and fast method used to assess the stability of tear film. It is a standard diagnostic procedure in the dry eye clinics. TFBUT is measured by determining the time to tear break-up. The TFBUT is performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient is instructed to blink several times to thoroughly mix the fluorescein with the tear film.\n\nA TFBUT greater than 15 seconds is considered normal, while a break time of less than 10 seconds is to be considered pathological.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Film Break-Up Time (TFBUT) vs Week 4 - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.10', 'ciUpperLimit': '1.74', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.225', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '1.10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 4', 'description': 'Tear film break-up time (TFBUT) is the time taken to appear first dry spot on cornea after a complete blinking. TFBUT measurement is an easy and fast method used to assess the stability of tear film. It is a standard diagnostic procedure in the dry eye clinics. TFBUT is measured by determining the time to tear break-up. The TFBUT is performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient is instructed to blink several times to thoroughly mix the fluorescein with the tear film.\n\nA TFBUT greater than 15 seconds is considered normal, while a break time of less than 10 seconds is to be considered pathological.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced a Worsening in Symptom Scores (SANDE) and/or NEI Score ≥ 50% Assessed at Week 4 - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.680', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.066', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 4', 'description': 'The SANDE score is calculated by taking the square root of the product of the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.\n\nThe NEI/Industry Workshop guidelines are used for grading the scale of corneal and conjunctival damage.\n\nThe cornea is divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, with a maximal total corneal staining score of 15.\n\nBoth nasally and temporally, the conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).\n\nBriefly, grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage in the considered sector.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced a Worsening in Symptom Scores (SANDE) and/or NEI Score ≥ 50% Assessed at Week 4 - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.076', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 4', 'description': 'The SANDE score is calculated by taking the square root of the product of the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.\n\nThe NEI/Industry Workshop guidelines are used for grading the scale of corneal and conjunctival damage.\n\nThe cornea is divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, with a maximal total corneal staining score of 15.\n\nBoth nasally and temporally, the conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).\n\nBriefly, grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage in the considered sector.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life (Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire vs Different Timepoints - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'title': 'Daily activity limitations - Chance from baseline to week 4', 'categories': [{'measurements': [{'value': '16.5', 'spread': '20.71', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '17.55', 'groupId': 'OG001'}, {'value': '13.1', 'spread': '20.60', 'groupId': 'OG002'}]}]}, {'title': 'Daily activity limitations - Chance from baseline to week 8', 'categories': [{'measurements': [{'value': '16.8', 'spread': '23.49', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '18.07', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '17.54', 'groupId': 'OG002'}]}]}, {'title': 'Daily activity limitations - Chance from baseline to week 12', 'categories': [{'measurements': [{'value': '15.7', 'spread': '21.10', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '20.01', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '17.45', 'groupId': 'OG002'}]}]}, {'title': 'Daily activity limitations - Chance from baseline to week 16', 'categories': [{'measurements': [{'value': '14.2', 'spread': '20.05', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '21.23', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '16.74', 'groupId': 'OG002'}]}]}, {'title': 'Emotional well-being - change from baseline to week 4', 'categories': [{'measurements': [{'value': '14.5', 'spread': '21.18', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '20.40', 'groupId': 'OG001'}, {'value': '15.0', 'spread': '20.47', 'groupId': 'OG002'}]}]}, {'title': 'Emotional well-being - change from baseline to week 8', 'categories': [{'measurements': [{'value': '16.2', 'spread': '21.33', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '18.64', 'groupId': 'OG001'}, {'value': '12.7', 'spread': '17.69', 'groupId': 'OG002'}]}]}, {'title': 'Emotional well-being - change from baseline to week 12', 'categories': [{'measurements': [{'value': '14.2', 'spread': '18.66', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '17.95', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '18.20', 'groupId': 'OG002'}]}]}, {'title': 'Emotional well-being - change from baseline to week 16', 'categories': [{'measurements': [{'value': '16.0', 'spread': '18.54', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '19.17', 'groupId': 'OG001'}, {'value': '13.5', 'spread': '20.22', 'groupId': 'OG002'}]}]}, {'title': 'work limitations - change from baseline to week 4', 'categories': [{'measurements': [{'value': '16.3', 'spread': '27.13', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '24.29', 'groupId': 'OG001'}, {'value': '17.4', 'spread': '24.09', 'groupId': 'OG002'}]}]}, {'title': 'work limitations - change from baseline to week 8', 'categories': [{'measurements': [{'value': '18.0', 'spread': '24.94', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '19.00', 'groupId': 'OG001'}, {'value': '17.0', 'spread': '22.52', 'groupId': 'OG002'}]}]}, {'title': 'work limitations - change from baseline to week 12', 'categories': [{'measurements': [{'value': '16.4', 'spread': '22.39', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '22.05', 'groupId': 'OG001'}, {'value': '17.8', 'spread': '22.35', 'groupId': 'OG002'}]}]}, {'title': 'work limitations - change from baseline to week 16', 'categories': [{'measurements': [{'value': '16.3', 'spread': '20.75', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '20.83', 'groupId': 'OG001'}, {'value': '16.0', 'spread': '21.63', 'groupId': 'OG002'}]}]}, {'title': 'Treatment satisfaction/happiness - change from baseline to week 4', 'categories': [{'measurements': [{'value': '24.1', 'spread': '30.81', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '30.57', 'groupId': 'OG001'}, {'value': '24.1', 'spread': '33.57', 'groupId': 'OG002'}]}]}, {'title': 'Treatment satisfaction/happiness - change from baseline to week 8', 'categories': [{'measurements': [{'value': '28.8', 'spread': '28.56', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '26.90', 'groupId': 'OG001'}, {'value': '13.3', 'spread': '30.69', 'groupId': 'OG002'}]}]}, {'title': 'Treatment satisfaction/happiness - change from baseline to week 12', 'categories': [{'measurements': [{'value': '26.1', 'spread': '30.30', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '27.86', 'groupId': 'OG001'}, {'value': '15.0', 'spread': '26.83', 'groupId': 'OG002'}]}]}, {'title': 'Treatment satisfaction/happiness - change from baseline to week 16', 'categories': [{'measurements': [{'value': '26.1', 'spread': '26.62', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '29.29', 'groupId': 'OG001'}, {'value': '12.7', 'spread': '27.03', 'groupId': 'OG002'}]}]}, {'title': 'treatment-related bother - change from baseline to week 4', 'categories': [{'measurements': [{'value': '14.6', 'spread': '22.78', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '25.00', 'groupId': 'OG001'}, {'value': '13.8', 'spread': '27.19', 'groupId': 'OG002'}]}]}, {'title': 'treatment-related bother - change from baseline to week 8', 'categories': [{'measurements': [{'value': '10.6', 'spread': '20.61', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '26.56', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '26.59', 'groupId': 'OG002'}]}]}, {'title': 'treatment-related bother - change from baseline to week 12', 'categories': [{'measurements': [{'value': '10.3', 'spread': '22.71', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '24.91', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '27.95', 'groupId': 'OG002'}]}]}, {'title': 'treatment-related bother - change from baseline to week 16', 'categories': [{'measurements': [{'value': '10.8', 'spread': '20.65', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '23.88', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '27.14', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye symptom bother - change from baseline to week 4', 'categories': [{'measurements': [{'value': '-16.8', 'spread': '17.80', 'groupId': 'OG000'}, {'value': '-17.7', 'spread': '16.54', 'groupId': 'OG001'}, {'value': '-16.5', 'spread': '17.04', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye symptom bother - change from baseline to week 8', 'categories': [{'measurements': [{'value': '-21.2', 'spread': '19.56', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '15.46', 'groupId': 'OG001'}, {'value': '-13.5', 'spread': '15.01', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye symptom bother - change from baseline to week 12', 'categories': [{'measurements': [{'value': '-19.6', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '-18.2', 'spread': '17.30', 'groupId': 'OG001'}, {'value': '-13.0', 'spread': '13.01', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye symptom bother - change from baseline to week 16', 'categories': [{'measurements': [{'value': '-19.9', 'spread': '15.62', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '17.75', 'groupId': 'OG001'}, {'value': '-11.1', 'spread': '14.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.289', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.4', 'ciLowerLimit': '12.0', 'ciUpperLimit': '20.8', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.032', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.7', 'ciLowerLimit': '15.4', 'ciUpperLimit': '24.0', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.095', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.4', 'ciLowerLimit': '11.9', 'ciUpperLimit': '20.8', 'groupDescription': 'Daily Activity Limitations - change to baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.282', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.5', 'ciLowerLimit': '10.1', 'ciUpperLimit': '18.8', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.169', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.0', 'ciLowerLimit': '10.6', 'ciUpperLimit': '19.4', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.129', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.4', 'ciLowerLimit': '11.1', 'ciUpperLimit': '19.7', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.111', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.0', 'ciLowerLimit': '9.7', 'ciUpperLimit': '18.4', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.107', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.0', 'ciLowerLimit': '9.7', 'ciUpperLimit': '18.3', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.827', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '9.7', 'ciUpperLimit': '18.9', 'groupDescription': 'Emotional Well-Being - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.688', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.3', 'ciLowerLimit': '11.8', 'ciUpperLimit': '20.8', 'groupDescription': 'Emotional Well-Being - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.324', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '11.4', 'ciUpperLimit': '20.0', 'groupDescription': 'Emotional Well-Being - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.949', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '8.7', 'ciUpperLimit': '17.1', 'groupDescription': 'Emotional Well-Being - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.927', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '11.4', 'ciUpperLimit': '20.1', 'groupDescription': 'Emotional Well-Being - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.776', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.8', 'ciLowerLimit': '10.8', 'ciUpperLimit': '18.8', 'groupDescription': 'Emotional Well-Being - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.418', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '11.4', 'ciUpperLimit': '20.1', 'groupDescription': 'Emotional Well-Being - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.613', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.8', 'ciLowerLimit': '10.6', 'ciUpperLimit': '19.0', 'groupDescription': 'Emotional Well-Being - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.721', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '8.3', 'ciUpperLimit': '23.2', 'groupDescription': 'Work Limitations - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.558', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.6', 'ciLowerLimit': '13.1', 'ciUpperLimit': '28.0', 'groupDescription': 'Work Limitations - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.809', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.4', 'ciLowerLimit': '11.5', 'ciUpperLimit': '25.3', 'groupDescription': 'Work Limitations - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.651', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.4', 'ciLowerLimit': '12.4', 'ciUpperLimit': '26.4', 'groupDescription': 'Work Limitations - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.769', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.4', 'ciLowerLimit': '9.5', 'ciUpperLimit': '23.3', 'groupDescription': 'Work Limitations - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.454', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '14.3', 'ciUpperLimit': '28.3', 'groupDescription': 'Work Limitations - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.564', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.3', 'ciLowerLimit': '11.6', 'ciUpperLimit': '25.0', 'groupDescription': 'Work Limitations - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.250', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.0', 'ciLowerLimit': '14.1', 'ciUpperLimit': '27.8', 'groupDescription': 'Work Limitations - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.853', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.9', 'ciLowerLimit': '15.6', 'ciUpperLimit': '32.2', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.393', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '11.9', 'ciUpperLimit': '28.0', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.9', 'ciLowerLimit': '20.2', 'ciUpperLimit': '35.6', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.395', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.3', 'ciLowerLimit': '11.1', 'ciUpperLimit': '25.4', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.8', 'ciLowerLimit': '17.1', 'ciUpperLimit': '32.4', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.400', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '12.2', 'ciUpperLimit': '26.4', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.5', 'ciLowerLimit': '18.1', 'ciUpperLimit': '33.0', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.056', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.1', 'ciLowerLimit': '16.1', 'ciUpperLimit': '30.0', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.981', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.2', 'ciLowerLimit': '7.6', 'ciUpperLimit': '20.7', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.525', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.0', 'ciLowerLimit': '11.1', 'ciUpperLimit': '22.9', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.356', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '2.9', 'ciUpperLimit': '16.0', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.771', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '0.7', 'ciUpperLimit': '12.4', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.926', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '2.0', 'ciUpperLimit': '15.5', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.778', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.9', 'ciLowerLimit': '1.9', 'ciUpperLimit': '13.9', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.984', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '10.0', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.514', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.4', 'ciLowerLimit': '1.6', 'ciUpperLimit': '13.1', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.985', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.6', 'ciLowerLimit': '-20.4', 'ciUpperLimit': '-12.8', 'groupDescription': 'Symptom Bother - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.646', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.8', 'ciLowerLimit': '-21.5', 'ciUpperLimit': '-14.0', 'groupDescription': 'Symptom Bother - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.7', 'ciLowerLimit': '-24.5', 'ciUpperLimit': '-16.9', 'groupDescription': 'Symptom Bother - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.305', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.2', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '-12.5', 'groupDescription': 'Symptom Bother - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.0', 'ciLowerLimit': '-22.7', 'ciUpperLimit': '-15.4', 'groupDescription': 'Symptom Bother - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.039', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.0', 'ciLowerLimit': '-21.5', 'ciUpperLimit': '-14.4', 'groupDescription': 'Symptom Bother - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.7', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '-16.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.9', 'ciLowerLimit': '-22.4', 'ciUpperLimit': '-15.3', 'groupDescription': 'Symptom Bother - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At weeks 4, 8, 12 and 16', 'description': 'IDEEL assesses quality of life, symptoms and treatment effects on patients with dry eye.\n\nThe IDEEL contains 3 modules (Daily Activities, Treatment Satisfaction, and Symptom Bother) with a total of 57 questions.\n\n1. The Daily Activities Module is the quality of life instrument. It is comprised of 27 items.\n2. The IDEEL Treatment Satisfaction and Bother Module is divided into 2 sections, Treatment - In General and Treatment - Eye Drops.\n3. The Symptom Bother Module consists of 20 items in a single content domain, Symptom Bother.\n\nScores for each dimensions ranged from 0 to 100.\n\nHigher scores for:\n\n* dimension of the Dry Eye Impact on Daily Life module indicates less impact on daily activities;\n* symptom-bother dimension indicates greater bother due to symptoms;\n* satisfaction with Treatment Effectiveness dimension indicates greater satisfaction with treatment effectiveness;\n* treatment-related bother/inconvenience indicates less treatment-related bother or inconvenience.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life (Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire vs Different Timepoints - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'title': 'Daily activity limitations - Change from baseline to week 4', 'categories': [{'measurements': [{'value': '16.8', 'spread': '21.20', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '17.58', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '20.63', 'groupId': 'OG002'}]}]}, {'title': 'Daily activity limitations - Change from baseline to week 8', 'categories': [{'measurements': [{'value': '17.1', 'spread': '23.93', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '16.85', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '17.47', 'groupId': 'OG002'}]}]}, {'title': 'Daily activity limitations - Change from baseline to week 12', 'categories': [{'measurements': [{'value': '17.0', 'spread': '20.30', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '18.45', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '17.64', 'groupId': 'OG002'}]}]}, {'title': 'Daily activity limitations - Change from baseline to week 16', 'categories': [{'measurements': [{'value': '13.9', 'spread': '19.33', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '19.74', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '16.94', 'groupId': 'OG002'}]}]}, {'title': 'Emotional well-being - change from baseline to week 4', 'categories': [{'measurements': [{'value': '15.2', 'spread': '21.73', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '20.33', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '20.60', 'groupId': 'OG002'}]}]}, {'title': 'Emotional well-being - change from baseline to week 8', 'categories': [{'measurements': [{'value': '16.9', 'spread': '21.70', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '18.34', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '17.55', 'groupId': 'OG002'}]}]}, {'title': 'Emotional well-being - change from baseline to week 12', 'categories': [{'measurements': [{'value': '15.1', 'spread': '18.58', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '16.87', 'groupId': 'OG001'}, {'value': '14.7', 'spread': '18.14', 'groupId': 'OG002'}]}]}, {'title': 'Emotional well-being - change from baseline to week 16', 'categories': [{'measurements': [{'value': '16.8', 'spread': '18.48', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '18.59', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '20.11', 'groupId': 'OG002'}]}]}, {'title': 'work limitations - change from baseline to week 4', 'categories': [{'measurements': [{'value': '16.0', 'spread': '27.48', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '24.83', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '24.23', 'groupId': 'OG002'}]}]}, {'title': 'work limitations - change from baseline to week 8', 'categories': [{'measurements': [{'value': '17.4', 'spread': '25.13', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '19.43', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '22.29', 'groupId': 'OG002'}]}]}, {'title': 'work limitations - change from baseline to week 12', 'categories': [{'measurements': [{'value': '15.0', 'spread': '21.67', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '21.82', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '22.14', 'groupId': 'OG002'}]}]}, {'title': 'work limitations - change from baseline to week 16', 'categories': [{'measurements': [{'value': '15.4', 'spread': '19.43', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '20.93', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '21.80', 'groupId': 'OG002'}]}]}, {'title': 'Treatment satisfaction/happiness - change from baseline to week 4', 'categories': [{'measurements': [{'value': '25.4', 'spread': '31.05', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '31.26', 'groupId': 'OG001'}, {'value': '25.2', 'spread': '33.81', 'groupId': 'OG002'}]}]}, {'title': 'Treatment satisfaction/happiness - change from baseline to week 8', 'categories': [{'measurements': [{'value': '30.1', 'spread': '28.47', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '27.85', 'groupId': 'OG001'}, {'value': '13.9', 'spread': '30.66', 'groupId': 'OG002'}]}]}, {'title': 'Treatment satisfaction/happiness - change from baseline to week 12', 'categories': [{'measurements': [{'value': '25.8', 'spread': '31.16', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '27.82', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '26.81', 'groupId': 'OG002'}]}]}, {'title': 'Treatment satisfaction/happiness - change from baseline to week 16', 'categories': [{'measurements': [{'value': '26.0', 'spread': '27.60', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '28.26', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '27.18', 'groupId': 'OG002'}]}]}, {'title': 'treatment-related bother - change from baseline to week 4', 'categories': [{'measurements': [{'value': '15.7', 'spread': '22.66', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '23.39', 'groupId': 'OG001'}, {'value': '14.4', 'spread': '27.71', 'groupId': 'OG002'}]}]}, {'title': 'treatment-related bother - change from baseline to week 8', 'categories': [{'measurements': [{'value': '11.6', 'spread': '20.73', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '25.46', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '26.78', 'groupId': 'OG002'}]}]}, {'title': 'treatment-related bother - change from baseline to week 12', 'categories': [{'measurements': [{'value': '9.9', 'spread': '22.83', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '23.05', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '28.26', 'groupId': 'OG002'}]}]}, {'title': 'treatment-related bother - change from baseline to week 16', 'categories': [{'measurements': [{'value': '11.4', 'spread': '20.90', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '21.62', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '27.51', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye symptom bother - change from baseline to week 4', 'categories': [{'measurements': [{'value': '-17.3', 'spread': '17.19', 'groupId': 'OG000'}, {'value': '-18.7', 'spread': '16.64', 'groupId': 'OG001'}, {'value': '-17.2', 'spread': '17.10', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye symptom bother - change from baseline to week 8', 'categories': [{'measurements': [{'value': '-21.5', 'spread': '18.88', 'groupId': 'OG000'}, {'value': '-17.6', 'spread': '15.40', 'groupId': 'OG001'}, {'value': '-13.9', 'spread': '14.97', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye symptom bother - change from baseline to week 12', 'categories': [{'measurements': [{'value': '-19.6', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '-19.7', 'spread': '17.16', 'groupId': 'OG001'}, {'value': '-13.2', 'spread': '13.18', 'groupId': 'OG002'}]}]}, {'title': 'Dry eye symptom bother - change from baseline to week 16', 'categories': [{'measurements': [{'value': '-20.6', 'spread': '15.21', 'groupId': 'OG000'}, {'value': '-20.7', 'spread': '17.66', 'groupId': 'OG001'}, {'value': '-11.3', 'spread': '14.61', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.241', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.8', 'ciLowerLimit': '12.2', 'ciUpperLimit': '21.4', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.040', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.7', 'ciLowerLimit': '15.1', 'ciUpperLimit': '24.4', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.8', 'ciLowerLimit': '12.3', 'ciUpperLimit': '21.4', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.238', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.3', 'ciLowerLimit': '10.7', 'ciUpperLimit': '19.9', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.070', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.5', 'ciLowerLimit': '12.0', 'ciUpperLimit': '20.9', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.058', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.7', 'ciLowerLimit': '12.3', 'ciUpperLimit': '21.1', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.7', 'ciLowerLimit': '9.3', 'ciUpperLimit': '18.1', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.024', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.0', 'ciLowerLimit': '11.6', 'ciUpperLimit': '20.3', 'groupDescription': 'Daily Activity Limitations - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.865', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.2', 'ciLowerLimit': '10.4', 'ciUpperLimit': '20.1', 'groupDescription': 'Emotional Well-Being - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.662', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.3', 'ciLowerLimit': '12.4', 'ciUpperLimit': '22.2', 'groupDescription': 'Emotional Well-Being - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.266', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.7', 'ciLowerLimit': '12.2', 'ciUpperLimit': '21.1', 'groupDescription': 'Emotional Well-Being - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.824', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.9', 'ciLowerLimit': '9.4', 'ciUpperLimit': '18.3', 'groupDescription': 'Emotional Well-Being - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.883', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.8', 'ciLowerLimit': '10.6', 'ciUpperLimit': '19.0', 'groupDescription': 'Emotional Well-Being - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.516', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.3', 'ciLowerLimit': '12.1', 'ciUpperLimit': '20.4', 'groupDescription': 'Emotional Well-Being - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.407', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.5', 'ciLowerLimit': '12.1', 'ciUpperLimit': '21.0', 'groupDescription': 'Emotional Well-Being - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Emotional Well-Being - change from baseline to week 16'}, {'pValue': '0.422', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.4', 'ciLowerLimit': '12.0', 'ciUpperLimit': '20.9', 'groupDescription': 'Emotional Well-Being - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.615', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.9', 'ciLowerLimit': '8.1', 'ciUpperLimit': '23.8', 'groupDescription': 'Work Limitations - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.626', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '13.3', 'ciUpperLimit': '29.2', 'groupDescription': 'Work Limitations - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.968', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.3', 'ciLowerLimit': '11.1', 'ciUpperLimit': '25.6', 'groupDescription': 'Work Limitations - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.689', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.1', 'ciLowerLimit': '12.8', 'ciUpperLimit': '27.4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.528', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.6', 'ciLowerLimit': '8.5', 'ciUpperLimit': '22.7', 'groupDescription': 'Work Limitations - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.368', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.0', 'ciLowerLimit': '15.8', 'ciUpperLimit': '30.1', 'groupDescription': 'Work Limitations - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.764', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.7', 'ciLowerLimit': '10.7', 'ciUpperLimit': '24.7', 'groupDescription': 'Work Limitations - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.184', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.6', 'ciLowerLimit': '15.5', 'ciUpperLimit': '29.6', 'groupDescription': 'Work Limitations - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.909', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.4', 'ciLowerLimit': '16.5', 'ciUpperLimit': '34.2', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.428', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.1', 'ciLowerLimit': '12.2', 'ciUpperLimit': '30.0', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.8', 'ciLowerLimit': '21.6', 'ciUpperLimit': '37.9', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.222', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '13.5', 'ciUpperLimit': '29.2', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.3', 'ciLowerLimit': '17.2', 'ciUpperLimit': '33.4', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.154', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.3', 'ciLowerLimit': '15.6', 'ciUpperLimit': '31.1', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.8', 'ciLowerLimit': '18.0', 'ciUpperLimit': '33.6', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.046', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.6', 'ciLowerLimit': '17.1', 'ciUpperLimit': '32.1', 'groupDescription': 'Treatment Satisfaction - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.861', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.4', 'ciLowerLimit': '8.6', 'ciUpperLimit': '22.2', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.865', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.3', 'ciLowerLimit': '9.0', 'ciUpperLimit': '21.7', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.5', 'ciLowerLimit': '3.6', 'ciUpperLimit': '17.3', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.689', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.2', 'ciLowerLimit': '0.9', 'ciUpperLimit': '13.5', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.993', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.1', 'ciLowerLimit': '2.1', 'ciUpperLimit': '16.2', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.989', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.2', 'ciLowerLimit': '2.8', 'ciUpperLimit': '15.7', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.976', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '3.7', 'ciUpperLimit': '17.0', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.778', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '2.9', 'ciUpperLimit': '15.1', 'groupDescription': 'Treatment-Related Bother - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.964', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.3', 'ciLowerLimit': '-21.2', 'ciUpperLimit': '-13.3', 'groupDescription': 'Symptom Bother - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.581', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.7', 'ciLowerLimit': '-22.7', 'ciUpperLimit': '-14.7', 'groupDescription': 'Symptom Bother - change from baseline to week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.4', 'ciLowerLimit': '-25.2', 'ciUpperLimit': '-17.5', 'groupDescription': 'Symptom Bother - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.175', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.6', 'ciLowerLimit': '-21.4', 'ciUpperLimit': '-13.7', 'groupDescription': 'Symptom Bother - change from baseline to week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.4', 'ciLowerLimit': '-23.1', 'ciUpperLimit': '-15.6', 'groupDescription': 'Symptom Bother - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.8', 'ciLowerLimit': '-23.5', 'ciUpperLimit': '-16.1', 'groupDescription': 'Symptom Bother - change from baseline to week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.5', 'ciLowerLimit': '-24.3', 'ciUpperLimit': '-16.8', 'groupDescription': 'Symptom Bother - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.8', 'ciLowerLimit': '-24.6', 'ciUpperLimit': '-17.1', 'groupDescription': 'Symptom Bother - change from baseline to week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At weeks 4, 8, 12 and 16', 'description': 'IDEEL assesses quality of life, symptoms and treatment effects on patients with dry eye.\n\nThe IDEEL contains 3 modules (Daily Activities, Treatment Satisfaction, and Symptom Bother) with a total of 57 questions.\n\n1. The Daily Activities Module is the quality of life instrument. It is comprised of 27 items.\n2. The IDEEL Treatment Satisfaction and Bother Module is divided into 2 sections, Treatment - In General and Treatment - Eye Drops.\n3. The Symptom Bother Module consists of 20 items in a single content domain, Symptom Bother.\n\nScores for each dimensions ranged from 0 to 100.\n\nHigher scores for:\n\n* dimension of the Dry Eye Impact on Daily Life module indicates less impact on daily activities;\n* symptom-bother dimension indicates greater bother due to symptoms;\n* satisfaction with Treatment Effectiveness dimension indicates greater satisfaction with treatment effectiveness;\n* treatment-related bother/inconvenience indicates less treatment-related bother or inconvenience.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'title': 'week 4 - Very Much Improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - Much Improved', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - Minimally improved', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - no change', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - minimally worse', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - Very much improved', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - much improved', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - minimally improved', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - no change', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - minimally worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - very much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - very much improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - much improved', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - minimally improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - no change', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - minimally worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - very much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - very much improved', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - much improved', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - minimally improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - no change', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - minimally worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.302', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'at week 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.224', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'at week 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'at week 8 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.885', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'at week 8 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'At week 12 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.698', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'At week 12 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'At week 16 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.706', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'At week 16 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline and weeks 4, 8, 12 and 16', 'description': 'PGIC is a commonly used method of assessing clinically important change. With PGIC the qualitative assessment of meaningful change is determined by the patient on 7-items using a 0 (very much improved) to 10 (very much worse) scale.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'title': 'week 4 - Very Much Improved', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - Much Improved', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - Minimally improved', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - no change', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - minimally worse', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 4 - very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - Very much improved', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - much improved', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - minimally improved', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - no change', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - minimally worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'week 8 - very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - very much improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - much improved', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - minimally improved', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - no change', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - minimally worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'week 12 - very much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - very much improved', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - much improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - minimally improved', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - no change', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - minimally worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'week 16 - very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.210', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'at week 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.260', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'at weeek 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'At week 8 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.734', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'at week 8 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.050', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'at week 12 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.985', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'at week 12 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'at week 16 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.580', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'at week 16 (FUP)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 4, 8, 12 and 16', 'description': 'PGIC is a commonly used method of assessing clinically important change. With PGIC the qualitative assessment of meaningful change is determined by the patient on 7-items using a 0 (very much improved) to 10 (very much worse) scale.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D-3L Questionnaire to Different Timepoints - Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'title': 'week 4', 'categories': [{'measurements': [{'value': '1.2', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '10.28', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '8.86', 'groupId': 'OG002'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '2.7', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '8.92', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '8.86', 'groupId': 'OG002'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '3.0', 'spread': '10.10', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '8.59', 'groupId': 'OG002'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '3.0', 'spread': '13.04', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '11.92', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '11.71', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.282', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '3.3', 'groupDescription': 'statistical analysis at week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.497', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '1.7', 'ciUpperLimit': '6.0', 'groupDescription': 'statistical analysis at week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.734', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '0.5', 'ciUpperLimit': '4.8', 'groupDescription': 'statistical analysis at week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.963', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.1', 'ciUpperLimit': '4.3', 'groupDescription': 'statistical analysis at week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.854', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '0.7', 'ciUpperLimit': '4.8', 'groupDescription': 'statistical analysis at week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.881', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '0.8', 'ciUpperLimit': '4.8', 'groupDescription': 'statistical analysis at week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.632', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '0.3', 'ciUpperLimit': '5.7', 'groupDescription': 'statistical analysis at week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.220', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '1.7', 'ciUpperLimit': '7.0', 'groupDescription': 'statistical analysis at week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At weeks 4, 8, 12 and 16', 'description': "EQ-5D is a standardised measure of health status. - The EQ-5D 3 level version (EQ-5D-3L) consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) which are summed up.\n\nThe EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This scale ranges from 5 (best case) to 15 (worst case).\n\nEach dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3). The respondent must indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.\n\n\\- The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This is a quantitative measure of health outcome, judged by each respondent.\n\nBoth for total and partial scores, the higher the score, the worse is the outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D-3L Questionnaire to Different Timepoints - Per Protocol Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'OG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'OG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'classes': [{'title': 'week 4', 'categories': [{'measurements': [{'value': '1.2', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '8.12', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '8.99', 'groupId': 'OG002'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '2.7', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '9.02', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '8.79', 'groupId': 'OG002'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '3.6', 'spread': '9.77', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '5.00', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '8.71', 'groupId': 'OG002'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '3.3', 'spread': '13.24', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '8.84', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '11.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '3.3', 'groupDescription': 'statistical analysis at week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.570', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '1.5', 'ciUpperLimit': '5.7', 'groupDescription': 'statistical analysis at week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.754', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '0.5', 'ciUpperLimit': '4.9', 'groupDescription': 'statistical analysis at week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.972', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '0.0', 'ciUpperLimit': '4.5', 'groupDescription': 'statistical analysis at week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.793', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '1.4', 'ciUpperLimit': '5.3', 'groupDescription': 'statistical analysis at week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.766', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '1.5', 'ciUpperLimit': '5.3', 'groupDescription': 'statistical analysis at week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.458', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '0.6', 'ciUpperLimit': '6.0', 'groupDescription': 'statistical analysis at week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.147', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '2.0', 'ciUpperLimit': '7.3', 'groupDescription': 'statistical analysis at week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Aat baseline and weeks 4, 8, 12 and 16', 'description': "EQ-5D is a standardised measure of health status. - The EQ-5D 3 level version (EQ-5D-3L) consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) which are summed up.\n\nThe EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This scale ranges from 5 (best case) to 15 (worst case).\n\nEach dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3). The respondent must indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.\n\n\\- The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This is a quantitative measure of health outcome, judged by each respondent.\n\nBoth for total and partial scores, the higher the score, the worse is the outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) set: The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'FG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'FG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '88'}]}, {'type': 'FAS Popuation', 'comment': 'The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint. This analysis set was used for the primary efficacy analysis. Patients were analyzed according to the randomized treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'PP Population', 'comment': 'The PP set consisted of all patients in the FAS who fulfilled the study protocol requirements in terms of IMP intake and collection of primary efficacy data and had no major deviations that may have affected study results. This analysis set was used for supportive efficacy analysis.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'unknow', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Enrollment of a total of 300 patients was planned. Due to restrictions in the hospital clinical routines related to coronavirus disease 2019, the sponsor decided to prematurely stop enrollment in the study in order to comply with quarantine measures of each country and avoid risks of infection of COVID-19 illness for all involved patients.\n\nA total of 261 patients were randomized to receive study treatment: 87 in the rhNGF TID group, 86 in the rhNGF BID group, and 88 in the vehicle TID group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '247', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)\n\nrhNGF 20 μg/ml: one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'BG001', 'title': 'rhNGF 20 μg/ml BID + Vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)\n\nrhNGF 20 μg/ml + vehicle: one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.'}, {'id': 'BG002', 'title': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)\n\nVehicle: one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '13.52', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '12.39', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '11.50', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '12.49', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '247', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Full analysis set (FAS): The FAS consisted of all patients randomized who took at least 1 dose of IMP and who had at least 1 postbaseline efficacy measurement for the primary endpoint.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-08', 'size': 3011881, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-09T06:42', 'hasProtocol': True}, {'date': '2019-08-08', 'size': 2018700, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-10T03:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2019-05-23', 'resultsFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2019-06-10', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-13', 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Schirmer I Test (Without Anesthesia) vs Week 4 - Full Analysis Set', 'timeFrame': 'Baseline, week 4', 'description': 'The Schirmer test is used in ophthalmic examination to measure tear production for the diagnosis of conditions such as keratoconjunctivitis sicca and dry eye.\n\nWithout previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.\n\nThe patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)\n\nCutoff values:\n\n\\<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \\>10 and \\<30 mm - normal secretion'}, {'measure': 'Change From Baseline in Schirmer I Test (Without Anesthesia) vs Week 4 - Per Protocol Set', 'timeFrame': 'Baseline, week 4', 'description': 'The Schirmer test is used in ophthalmic examination to measure tear production for the diagnosis of conditions such as keratoconjunctivitis sicca and dry eye.\n\nWithout previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.\n\nThe patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)\n\nCutoff values:\n\n\\<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \\>10 and \\<30 mm - normal secretion'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Severity vs Week 4 - Full Analysis Set', 'timeFrame': 'Baseline, week 4', 'description': 'The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The global score is calculated by taking the square root of the product of the severity of symptoms per the frequency of symptoms. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.'}, {'measure': 'Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Severity vs Week 4 - Per Protocol Set', 'timeFrame': 'Baseline, week 4', 'description': 'The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The global score is calculated by taking the square root of the product of the severity of symptoms per the frequency of symptoms. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.'}, {'measure': 'Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Frequency vs Week 4 - Full Analysis Set', 'timeFrame': 'Baseline, week 4', 'description': 'The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome.The SANDE global score is calculated by taking the square root of the product of the frequency of symptoms and the severity of symptoms. The SANDE scale ranges from 0 to 100 wi.100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms'}, {'measure': 'Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Frequency vs Week 4 - Per Protocol Set', 'timeFrame': 'Baseline, week 4', 'description': 'The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score. The SANDE scale ranges from 0 to 100 wi.100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.'}, {'measure': 'Change From Baseline in Schirmer II Test (With Anesthesia) vs Week 4 - Full Analysis Set', 'timeFrame': 'Baseline, week 4', 'description': 'The Schirmer II test is performed as the Schirmer I test after instilling anesthetic drops. The Schirmer strips are inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. All patients are seated at rest with their eyes closed, and the lower cul-de-sac is gently dried with a cotton applicator before the placement of strips.\n\nCut-off values:\n\n\\<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \\>10 and \\<30 mm - normal secretion'}, {'measure': 'Change From Baseline in Schirmer II Test (With Anesthesia) vs Week 4 - Per Protocol Set', 'timeFrame': 'Baseline, week 4', 'description': 'The Schirmer II test is performed as the Schirmer I test after instilling anesthetic drops. The Schirmer strips are inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.\n\nAll patients are seated at rest with their eyes closed, and the lower cul-de-sac is gently dried with a cotton applicator before the placement of strips.\n\nCut-off values:\n\n\\<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \\>10 and \\<30 mm - normal secretion'}, {'measure': 'Change From Baseline in Corneal and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) vs Week 4 - Full Analysis Set', 'timeFrame': 'Baseline, week 4', 'description': 'Corneal staining total score is defined as the sum of scores from 5 corneal areas: Central, Superior, Temporal, Nasal, and Inferior. The score for each area ranges from 0 to 3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage. Thus, the corneal staining total score can range from 0 to 15 where the higher the score the worse is the outcome.\n\nThe conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage and with a maximal score of 9 for the nasal and temporal conjunctiva. Thus, the conjunctival staining total score can range from 0 to 18 where the higher the score the worse is the outcome.\n\nCorneal and conjunctiva vital staining total score is the sum of corneal staining total score and conjunctiva total score.'}, {'measure': 'Change From Baseline in Corneal and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) vs Week 4 - Per Protocol Set', 'timeFrame': 'Baseline, week 4', 'description': 'Corneal staining total score is defined as the sum of scores from 5 corneal areas: Central, Superior, Temporal, Nasal, and Inferior. The score for each area ranges from 0 to 3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage. Thus, the corneal staining total score can range from 0 to 15 where the higher the score the worse is the outcome.\n\nThe conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage and with a maximal score of 9 for the nasal and temporal conjunctiva. Thus, the conjunctival staining total score can range from 0 to 18 where the higher the score the worse is the outcome.\n\nCorneal and conjunctiva vital staining total score is the sum of corneal staining total score and conjunctiva total score.'}, {'measure': 'Change From Baseline in Tear Film Break-Up Time (TFBUT) vs Week 4 - Full Analysis Set', 'timeFrame': 'Baseline, week 4', 'description': 'Tear film break-up time (TFBUT) is the time taken to appear first dry spot on cornea after a complete blinking. TFBUT measurement is an easy and fast method used to assess the stability of tear film. It is a standard diagnostic procedure in the dry eye clinics. TFBUT is measured by determining the time to tear break-up. The TFBUT is performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient is instructed to blink several times to thoroughly mix the fluorescein with the tear film.\n\nA TFBUT greater than 15 seconds is considered normal, while a break time of less than 10 seconds is to be considered pathological.'}, {'measure': 'Change From Baseline in Tear Film Break-Up Time (TFBUT) vs Week 4 - Per Protocol Set', 'timeFrame': 'Baseline, week 4', 'description': 'Tear film break-up time (TFBUT) is the time taken to appear first dry spot on cornea after a complete blinking. TFBUT measurement is an easy and fast method used to assess the stability of tear film. It is a standard diagnostic procedure in the dry eye clinics. TFBUT is measured by determining the time to tear break-up. The TFBUT is performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient is instructed to blink several times to thoroughly mix the fluorescein with the tear film.\n\nA TFBUT greater than 15 seconds is considered normal, while a break time of less than 10 seconds is to be considered pathological.'}, {'measure': 'Number of Patients Who Experienced a Worsening in Symptom Scores (SANDE) and/or NEI Score ≥ 50% Assessed at Week 4 - Full Analysis Set', 'timeFrame': 'At week 4', 'description': 'The SANDE score is calculated by taking the square root of the product of the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.\n\nThe NEI/Industry Workshop guidelines are used for grading the scale of corneal and conjunctival damage.\n\nThe cornea is divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, with a maximal total corneal staining score of 15.\n\nBoth nasally and temporally, the conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).\n\nBriefly, grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage in the considered sector.'}, {'measure': 'Number of Patients Who Experienced a Worsening in Symptom Scores (SANDE) and/or NEI Score ≥ 50% Assessed at Week 4 - Per Protocol Set', 'timeFrame': 'At week 4', 'description': 'The SANDE score is calculated by taking the square root of the product of the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.\n\nThe NEI/Industry Workshop guidelines are used for grading the scale of corneal and conjunctival damage.\n\nThe cornea is divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, with a maximal total corneal staining score of 15.\n\nBoth nasally and temporally, the conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).\n\nBriefly, grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage in the considered sector.'}, {'measure': 'Change From Baseline in Quality of Life (Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire vs Different Timepoints - Full Analysis Set', 'timeFrame': 'At weeks 4, 8, 12 and 16', 'description': 'IDEEL assesses quality of life, symptoms and treatment effects on patients with dry eye.\n\nThe IDEEL contains 3 modules (Daily Activities, Treatment Satisfaction, and Symptom Bother) with a total of 57 questions.\n\n1. The Daily Activities Module is the quality of life instrument. It is comprised of 27 items.\n2. The IDEEL Treatment Satisfaction and Bother Module is divided into 2 sections, Treatment - In General and Treatment - Eye Drops.\n3. The Symptom Bother Module consists of 20 items in a single content domain, Symptom Bother.\n\nScores for each dimensions ranged from 0 to 100.\n\nHigher scores for:\n\n* dimension of the Dry Eye Impact on Daily Life module indicates less impact on daily activities;\n* symptom-bother dimension indicates greater bother due to symptoms;\n* satisfaction with Treatment Effectiveness dimension indicates greater satisfaction with treatment effectiveness;\n* treatment-related bother/inconvenience indicates less treatment-related bother or inconvenience.'}, {'measure': 'Change From Baseline in Quality of Life (Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire vs Different Timepoints - Per Protocol Set', 'timeFrame': 'At weeks 4, 8, 12 and 16', 'description': 'IDEEL assesses quality of life, symptoms and treatment effects on patients with dry eye.\n\nThe IDEEL contains 3 modules (Daily Activities, Treatment Satisfaction, and Symptom Bother) with a total of 57 questions.\n\n1. The Daily Activities Module is the quality of life instrument. It is comprised of 27 items.\n2. The IDEEL Treatment Satisfaction and Bother Module is divided into 2 sections, Treatment - In General and Treatment - Eye Drops.\n3. The Symptom Bother Module consists of 20 items in a single content domain, Symptom Bother.\n\nScores for each dimensions ranged from 0 to 100.\n\nHigher scores for:\n\n* dimension of the Dry Eye Impact on Daily Life module indicates less impact on daily activities;\n* symptom-bother dimension indicates greater bother due to symptoms;\n* satisfaction with Treatment Effectiveness dimension indicates greater satisfaction with treatment effectiveness;\n* treatment-related bother/inconvenience indicates less treatment-related bother or inconvenience.'}, {'measure': 'Patient Global Impression of Change (PGIC) - Full Analysis Set', 'timeFrame': 'At baseline and weeks 4, 8, 12 and 16', 'description': 'PGIC is a commonly used method of assessing clinically important change. With PGIC the qualitative assessment of meaningful change is determined by the patient on 7-items using a 0 (very much improved) to 10 (very much worse) scale.'}, {'measure': 'Patient Global Impression of Change (PGIC) - Per Protocol Set', 'timeFrame': 'At weeks 4, 8, 12 and 16', 'description': 'PGIC is a commonly used method of assessing clinically important change. With PGIC the qualitative assessment of meaningful change is determined by the patient on 7-items using a 0 (very much improved) to 10 (very much worse) scale.'}, {'measure': 'Change From Baseline in EQ-5D-3L Questionnaire to Different Timepoints - Full Analysis Set', 'timeFrame': 'At weeks 4, 8, 12 and 16', 'description': "EQ-5D is a standardised measure of health status. - The EQ-5D 3 level version (EQ-5D-3L) consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) which are summed up.\n\nThe EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This scale ranges from 5 (best case) to 15 (worst case).\n\nEach dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3). The respondent must indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.\n\n\\- The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This is a quantitative measure of health outcome, judged by each respondent.\n\nBoth for total and partial scores, the higher the score, the worse is the outcome."}, {'measure': 'Change From Baseline in EQ-5D-3L Questionnaire to Different Timepoints - Per Protocol Set', 'timeFrame': 'Aat baseline and weeks 4, 8, 12 and 16', 'description': "EQ-5D is a standardised measure of health status. - The EQ-5D 3 level version (EQ-5D-3L) consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) which are summed up.\n\nThe EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This scale ranges from 5 (best case) to 15 (worst case).\n\nEach dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3). The respondent must indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.\n\n\\- The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This is a quantitative measure of health outcome, judged by each respondent.\n\nBoth for total and partial scores, the higher the score, the worse is the outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'referencesModule': {'references': [{'pmid': '39020305', 'type': 'DERIVED', 'citation': 'Wirta D, Lipsky W, Toyos M, Martel J, Goosey J, Verachtert A, El-Harazi S, Karpecki P, Allegretti M, Goisis G, Pasedis G, Mantelli F. Recombinant human nerve growth factor (cenegermin) for moderate-to-severe dry eye: phase II, randomized, vehicle-controlled, dose-ranging trial. BMC Ophthalmol. 2024 Jul 17;24(1):290. doi: 10.1186/s12886-024-03564-w.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety of rhNGF eye drops at 20 μg/ml concentration administered two or three times daily for 4 weeks in patients with moderate to severe dry eye.', 'detailedDescription': 'This is a 4 weeks, Phase II, multicenter, randomized, double-masked, vehicle-controlled, parallel group study with 12 weeks of follow-up, designed to perform dose-ranging and to evaluate safety and efficacy of recombinant human Nerve Growth Factor (rhNGF) eye drops solution versus vehicle, in patients with moderate to severe dry eye (DE).\n\nTest product is rhNGF 20 μg/ml; reference product is vehicle. Test and reference will be instilled in both eyes according to the following scheme:\n\nGroup 1: one drop of rhNGF 20 μg/ml is instilled in both eyes three times daily (every 6-8 hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).\n\nGroup 2: one drop of rhNGF 20 μg/ml is instilled in both eyes two times daily (in the morning and in the evening) plus one drop (40 μL) of vehicle (placebo) is instilled in both eyes once daily in the afternoon.\n\nGroup 3: one drop (40 μL) of vehicle (placebo) is instilled in both eyes three times daily (every 6-8 hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).\n\nApproximate randomization 1:1:1 of 261 patients to rhNGF eye drops solution 20 μg/ml TID (87 patients) or rhNGF eye drops solution 20 μg/ml BID + vehicle eye drop SID (86 patients) or vehicle eye drops solution (88 patients) TID for 4 weeks was applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female aged ≥ 18 years\n2. Patients with moderate to severe dry eye characterized by the following clinical features:\n\n 1. Corneal and/or conjunctival staining with fluorescein using National Eye Institute (NEI) grading system \\> 3\n 2. SANDE questionnaire \\>25 mm\n 3. Schirmer test I (without anaesthesia) \\>2mm \\<10 mm/5 minutes\n 4. Tear film break-up time (TFBUT) \\< 10 seconds in the worse eye\n3. The same eye (eligible eye) must fulfill all the above criteria\n4. Patients diagnosed with dry eye at least 6 months before enrolment (current use or recommended use of artificial tears for the treatment of Dry Eye)\n5. Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units (20/200 Snellen value) in both eyes at the time of study enrolment\n6. If a female of childbearing potential, have a negative pregnancy test\n7. Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the Institutional Review Board (IRB) / Independent Ethics Committee (IEC) for the current study\n8. Patients must have the ability and willingness to comply with study procedures.\n\nExclusion Criteria:\n\n1. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments;\n2. Evidence of an active ocular infection, in either eye\n3. Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study\n4. History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than dry eye\n5. Intraocular inflammation defined as Tyndall score \\>0\n6. History of malignancy in the last 5 years\n7. Systemic disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, thyroid malfunction..) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or with a condition incompatible with the frequent assessment required by the study\n8. Patient had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or had a clinically significant allergy to drugs, foods, amide local anaesthetics or other materials including commercial artificial tears (in the opinion of the investigator)\n9. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:\n\n 1. are currently pregnant or,\n 2. have a positive result at the urine pregnancy test (Baseline/Day 0) or,\n 3. intend to become pregnant during the study treatment period or,\n 4. are breast-feeding or,\n 5. are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or Intra Uterine Device (IUD) - during the entire course of and 30 days after the study treatment periods\n10. Any concurrent medical condition, that in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being\n11. Use of topical cyclosporine, topical corticosteroids or any other topical drug for the treatment of dry eye in either eye within 30 days of study enrolment.\n12. Contact lenses or punctum plug use during the study (previous use not an exclusion criteria but must be discontinued at the screening visit)\n13. History of drug addiction or alcohol abuse\n14. Any prior ocular surgery (including refractive palpebral and cataract surgery) if within 90 days before the screening visit\n15. Participation in a clinical trial with a new active substance during the past 6 months\n16. Participation in another clinical trial study at the same time as the present study."}, 'identificationModule': {'nctId': 'NCT03982368', 'briefTitle': 'A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dompé Farmaceutici S.p.A'}, 'officialTitle': 'A 4 Weeks, Phase II, Multicenter, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 12 Weeks of Follow-up to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution vs Vehicle in Moderate to Severe Dry Eye.', 'orgStudyIdInfo': {'id': 'NGF0118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rhNGF 20 μg/ml TID', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)', 'interventionNames': ['Drug: rhNGF 20 μg/ml']}, {'type': 'EXPERIMENTAL', 'label': 'rhNGF 20 μg/ml BID + vehicle OD', 'description': 'One drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)', 'interventionNames': ['Drug: rhNGF 20 μg/ml + vehicle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle TID', 'description': 'Vehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)', 'interventionNames': ['Other: Vehicle']}], 'interventions': [{'name': 'rhNGF 20 μg/ml', 'type': 'DRUG', 'otherNames': ['cenegermin'], 'description': 'one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)', 'armGroupLabels': ['rhNGF 20 μg/ml TID']}, {'name': 'rhNGF 20 μg/ml + vehicle', 'type': 'DRUG', 'otherNames': ['cenegermin + placebo'], 'description': 'one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).\n\nrhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.', 'armGroupLabels': ['rhNGF 20 μg/ml BID + vehicle OD']}, {'name': 'Vehicle', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': 'one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)', 'armGroupLabels': ['Vehicle TID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Management', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Martel Eye Medical Group', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '92647', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Sierra Clinical Trials & Research Organization', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clayton Eye Clinical Research, LLC', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'zip': '40517', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Eye Institute', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Tauber Eye Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Moyes Eye Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '11702', 'city': 'Babylon', 'state': 'New York', 'country': 'United States', 'facility': 'SightMD', 'geoPoint': {'lat': 40.69566, 'lon': -73.32568}}, {'zip': '37027', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Toyos Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Eye Associates HEA - Gramercy Location', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Laser Vision Surgical Institute (Study Site) Intouch Clinical Research Center (SMO)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Flavio Mantelli, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dompé Farmaceutici SpA'}, {'name': 'William Lipsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Laser Vision Surgical Institute (Study Site) Intouch Clinical Research Center (SMO)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dompé Farmaceutici S.p.A', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}