Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-01 @ 6:42 PM
Study NCT ID:
NCT03990051
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chang@gliacell.com', 'phone': '(617) 794-8922', 'title': 'Wei-wei Chang, PhD; President', 'organization': 'Glia, LLC'}, 'certainAgreement': {'otherDetails': 'Sponsor has prior review rights before publications or presentations.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Pro-ocular™ for 2 Years', 'description': 'Pro-ocular™ 1% topical gel applied to forehead twice daily', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Pro-ocular™ for 10-week Masked Period Only', 'description': 'Pro-ocular™ 1% topical gel applied to forehead twice daily for 10-week masked period only', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 17, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo+Active for 2 Years Total', 'description': 'Placebo topical gel applied to forehead twice daily. Placebo gel for the first 10 weeks of masked period, followed by active gel for the remaining 2 year period', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Placebo for 10-week Masked Period Ony', 'description': 'Placebo topical gel applied to forehead twice daily. Placebo gel for the first 10 weeks of masked period only', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 8, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'notes': 'Headaches were light and brief, lasting 10 min to 2 hours, occurring within the first 2 weeks of the study only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rhinorrhea', 'notes': 'Rhinorrhea or runny nose in almost all cases were brief, and occurred within the first 2 weeks of the study only.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute lymphocytic leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Endocrine neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vascular operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Iron deficiency anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal thinning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal epithelium defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Mycardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neurosensory hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ophthalmic herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Parathyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Modified SANDE Questionnaire - Frequency, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead tBID'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.00', 'spread': '4.246', 'groupId': 'OG000'}, {'value': '-4.59', 'spread': '6.009', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0197', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline, Active - Placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Fluorescein Stain - Central, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.213', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.304', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified SANDE Questionnaire - Frequency, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.75', 'spread': '4.313', 'groupId': 'OG000'}, {'value': '-1.95', 'spread': '6.009', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified SANDE Questionnaire - Frequency, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.72', 'spread': '4.313', 'groupId': 'OG000'}, {'value': '-2.18', 'spread': '6.009', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Fluorescein Stain - Central, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel applied dermally to forehead twice daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel applied dermally to forehead twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.304', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0138', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Fluorescein Stain - Central, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.307', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified SANDE Questionnaire - Global, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.02', 'spread': '4.063', 'groupId': 'OG000'}, {'value': '-3.78', 'spread': '5.753', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0849', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified SANDE Questionnaire - Global, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.35', 'spread': '4.128', 'groupId': 'OG000'}, {'value': '-5.64', 'spread': '5.753', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0041', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified SANDE Questionnaire - Global, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.87', 'spread': '4.128', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.006', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Fluorescein Stain - Total, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.53', 'spread': '0.527', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.753', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0143', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Fluorescein Stain - Total, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.28', 'spread': '0.537', 'groupId': 'OG000'}, {'value': '-1.35', 'spread': '0.753', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0398', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Fluorescein Stain - Total, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.97', 'spread': '0.537', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '0.763', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '-3.97', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blurred Vision, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.07', 'spread': '0.400', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.568', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blurred Vision, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.09', 'spread': '0.404', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.568', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blurred Vision, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.23', 'spread': '0.404', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.568', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0067', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Photophobia, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.432', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.695', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0636', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nSensitivity to light symptom is reported by participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Photophobia, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.68', 'spread': '0.437', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.613', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nSensitivity to light symptom is reported by participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Photophobia, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.82', 'spread': '0.437', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.612', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0067', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nSensitivity to light symptom is reported by participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lid Edema, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.73', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.293', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0105', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is viewed by slit lamp without stain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lid Edema, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.21', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '0.293', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is viewed by slit lamp without stain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lid Edema, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.72', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '0.293', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0155', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is viewed by slit lamp without stain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lid Erythema, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.224', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.317', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0160', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is viewed by slit lamp without stain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lid Erythema, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel forehead BID'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo topical gel forehead BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.53', 'spread': '0.229', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.317', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0117', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of changes in score from baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. 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Symptom Assessment iN Dry Eye Questionnaire. 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Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Modified SANDE Questionnaire - Global', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 2 Years', 'description': 'All participants combined at 2 years as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '74.39', 'spread': '16.620', 'groupId': 'OG000'}, {'value': '31.04', 'spread': '22.037', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 years', 'description': 'Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Corneal Fluorescein Stain - Central', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 1 Year', 'description': 'All participants combined at 1 year as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.57', 'spread': '2.779', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '1.522', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 year', 'description': 'Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Corneal Fluorescein Stain - Central', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 2 Years', 'description': 'All participants combined at 2 years as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.57', 'spread': '2.779', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '1.224', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 years', 'description': 'Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Corneal Fluorescein Stain - Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 1 Year', 'description': 'All participants combined at 1 year as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.52', 'spread': '7.137', 'groupId': 'OG000'}, {'value': '3.65', 'spread': '3.289', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 year', 'description': 'Fluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Corneal Fluorescein Stain - Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 2 Years', 'description': 'All participants combined at 2 years as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.52', 'spread': '7.137', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '3.699', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 years', 'description': 'Fluorescein staining score Total for worse eye. Total comprises Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blurred Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 1 Year', 'description': 'All participants combined at 1 year as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.59', 'spread': '2.610', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '2.582', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 year', 'description': 'Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blurred Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 2 Years', 'description': 'All participants combined at 2 years as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.59', 'spread': '2.610', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '2.768', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 years', 'description': 'Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lid Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 1 Year', 'description': 'All participants combined at 1 year as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.74', 'spread': '2.785', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.995', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 year', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lid Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 2 Years', 'description': 'All participants combined at 2 years as all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.74', 'spread': '2.785', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '1.085', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 years', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lid Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 1 Year', 'description': 'All participants combined at 1 year all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.92', 'spread': '2.738', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '1.457', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 year', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lid Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 2 Years', 'description': 'All participants combined at 2 years all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.92', 'spread': '2.738', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 years', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lid Ulceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 1 Year', 'description': 'All participants combined at 1 year all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.07', 'spread': '2.289', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '1.143', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 year', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lid Ulceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 2 Years', 'description': 'All participants combined at 2 years all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.07', 'spread': '2.289', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.628', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 years', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Conjunctival Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 1 Year', 'description': 'All participants combined at 1 year all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '2.354', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.238', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 year', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nConjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Conjunctival Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pro-ocular + Placebo Baseline', 'description': 'All participants combined as one group at baseline'}, {'id': 'OG001', 'title': 'Pro-ocular + Placebo at 2 Years', 'description': 'All participants combined at 2 years all were on active after 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '2.354', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.886', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 years', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nConjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.\n\nPro-ocular™ group received active for 2 years beginning with first dose. The first 10 weeks were masks, whereas the remaining time was open-label active.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.\n\nPlacebo group was dosed with placebo topical gel for the first 10 weeks, followed by open-label active for the remainder of 2 years from first dosing.'}], 'periods': [{'title': 'Masked Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Long Term Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Double masked phase 10 weeks. Both Pro-ocular and Placebo groups received active treatment after 10 weeks for remainder of 2 years total from first dose..'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo topical gel'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '12.48', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '13.20', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '12.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ocular Graft versus Host Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time of HSCT to oGvHD Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '22.5', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '49.9', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '33.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NIH Eye Score', 'classes': [{'categories': [{'title': 'Score 0-1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Score 2', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Score 3', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The NIH Eye Score is a scoring system used to measure the severity of dry eyes in patients with chronic ocular graft-versus-host disease (GVHD). The score ranges from 0-3, with 0 indicating no dry eye, 1 indicating mild dry eye, 2 indicating moderate dry eye, and 3 indicating severe dry eye.', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant artificial tears and gel', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Concomitant artificial tears and gel use', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant ocular corticosteroid', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Concomitant ocular corticosteroid use.', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant ocular ciclosporin', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Concomitant ciclosporin eye drops use.', 'unitOfMeasure': 'Participants'}, {'title': 'Punctal plugs history', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ever had punctal plugs inserted', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant systemic anti-inflammatory', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Concomitant use of systemic anti-inflammatory medications', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-17', 'size': 934004, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-14T20:06', 'hasProtocol': True}, {'date': '2019-09-18', 'size': 616757, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-14T20:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomized double-masked parallel treatment assignment will be made using a block design at the ratio of 2:1, study drug:placebo, (22 subjects:11 subjects). This 70-day double-masked phase will be followed by 6 weeks open-label active drug treatment of the subjects previously on placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The double-masked phase involves placebo controlled administration of study drug for 70 days or 10 weeks. Subsequently the placebo group will receive the active study drug of 42 days or 6 weeks. Long term open label phase to 27 months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2019-06-11', 'resultsFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2019-06-15', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-16', 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Modified SANDE Questionnaire - Frequency', 'timeFrame': '1 year', 'description': 'Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?'}, {'measure': 'Modified SANDE Questionnaire - Frequency', 'timeFrame': '2 years', 'description': 'Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?'}, {'measure': 'Modified SANDE Questionnaire - Global', 'timeFrame': '1 year', 'description': 'Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?'}, {'measure': 'Modified SANDE Questionnaire - Global', 'timeFrame': '2 years', 'description': 'Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?'}, {'measure': 'Corneal Fluorescein Stain - Central', 'timeFrame': '1 year', 'description': 'Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.'}, {'measure': 'Corneal Fluorescein Stain - Central', 'timeFrame': '2 years', 'description': 'Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.'}, {'measure': 'Corneal Fluorescein Stain - Total', 'timeFrame': '1 year', 'description': 'Fluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.'}, {'measure': 'Corneal Fluorescein Stain - Total', 'timeFrame': '2 years', 'description': 'Fluorescein staining score Total for worse eye. Total comprises Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.'}, {'measure': 'Blurred Vision', 'timeFrame': '1 year', 'description': 'Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.'}, {'measure': 'Blurred Vision', 'timeFrame': '2 years', 'description': 'Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.'}, {'measure': 'Lid Edema', 'timeFrame': '1 year', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.'}, {'measure': 'Lid Edema', 'timeFrame': '2 years', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.'}, {'measure': 'Lid Erythema', 'timeFrame': '1 year', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.'}, {'measure': 'Lid Erythema', 'timeFrame': '2 years', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.'}, {'measure': 'Lid Ulceration', 'timeFrame': '1 year', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining.'}, {'measure': 'Lid Ulceration', 'timeFrame': '2 years', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.'}, {'measure': 'Conjunctival Hyperemia', 'timeFrame': '1 year', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nConjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.'}, {'measure': 'Conjunctival Hyperemia', 'timeFrame': '2 years', 'description': 'Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.\n\nConjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.'}], 'primaryOutcomes': [{'measure': 'Modified SANDE Questionnaire - Frequency, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?'}, {'measure': 'Corneal Fluorescein Stain - Central, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Modified SANDE Questionnaire - Frequency, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?'}, {'measure': 'Modified SANDE Questionnaire - Frequency, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?'}, {'measure': 'Corneal Fluorescein Stain - Central, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.'}, {'measure': 'Corneal Fluorescein Stain - Central, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.'}, {'measure': 'Modified SANDE Questionnaire - Global, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.'}, {'measure': 'Modified SANDE Questionnaire - Global, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.'}, {'measure': 'Modified SANDE Questionnaire - Global, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.\n\nSymptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.'}, {'measure': 'Corneal Fluorescein Stain - Total, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.'}, {'measure': 'Corneal Fluorescein Stain - Total, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.'}, {'measure': 'Corneal Fluorescein Stain - Total, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.'}, {'measure': 'Blurred Vision, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.'}, {'measure': 'Blurred Vision, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.'}, {'measure': 'Blurred Vision, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.\n\nBlurred vision symptom is reported by participant.'}, {'measure': 'Photophobia, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nSensitivity to light symptom is reported by participant.'}, {'measure': 'Photophobia, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nSensitivity to light symptom is reported by participant.'}, {'measure': 'Photophobia, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.\n\nSensitivity to light symptom is reported by participant.'}, {'measure': 'Lid Edema, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is viewed by slit lamp without stain.'}, {'measure': 'Lid Edema, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is viewed by slit lamp without stain.'}, {'measure': 'Lid Edema, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid edema is viewed by slit lamp without stain.'}, {'measure': 'Lid Erythema, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is viewed by slit lamp without stain.'}, {'measure': 'Lid Erythema, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is viewed by slit lamp without stain.'}, {'measure': 'Lid Erythema, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid erythema is viewed by slit lamp without stain.'}, {'measure': 'Lid Margin Ulceration, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid margin ulceration is viewed by slit lamp without stain.'}, {'measure': 'Lid Margin Ulceration, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid margin ulceration is viewed by slit lamp without stain.'}, {'measure': 'Lid Margin Ulceration, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nLid margin ulceration is viewed by slit lamp without stain.'}, {'measure': 'Conjunctival Hyperemia, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nConjunctival hyperemia is viewed by slit lamp without stain.'}, {'measure': 'Conjunctival Hyperemia, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nConjunctival hyperemia is viewed by slit lamp without stain.'}, {'measure': 'Conjunctival Hyperemia, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nConjunctival hyperemia is viewed by slit lamp without stain.'}, {'measure': 'Dryness, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nDryness symptom is reported by participant.'}, {'measure': 'Dryness, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nDryness symptom is reported by participant.'}, {'measure': 'Dryness, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nDryness symptom is reported by participant.'}, {'measure': 'Ocular Pain, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nOcular pain symptom is reported by participant.'}, {'measure': 'Ocular Pain, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nOcular pain symptom is reported by participant.'}, {'measure': 'Ocular Pain, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nOcular pain symptom is reported by participant.'}, {'measure': 'Airflow Sensitivity, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nAirflow sensitivity symptom is reported by participant.'}, {'measure': 'Airflow Sensitivity, Change From Baseline', 'timeFrame': '6 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nAirflow sensitivity symptom is reported by participant.'}, {'measure': 'Airflow Sensitivity, Change From Baseline', 'timeFrame': '10 weeks', 'description': 'Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.\n\nAirflow sensitivity symptom is reported by participant.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Ocular Graft-versus-host Disease']}, 'referencesModule': {'references': [{'pmid': '33942724', 'type': 'RESULT', 'citation': 'Luo ZK, Domenech-Estarellas EA, Han A, Lee D, Khatri R, Wahl JL, Cutler C, Armand P, Antin JH, Koreth J, Gooptu M, Alyea EP, Soiffer RJ, Ho VT. Efficacy and Safety of 1% Progesterone Gel to the Forehead for Ocular Chronic Graft-versus-Host Disease. Transplant Cell Ther. 2021 May;27(5):433.e1-433.e8. doi: 10.1016/j.jtct.2021.02.008. Epub 2021 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.', 'detailedDescription': 'Ocular graft versus host disease presents a most severe form of ocular surface disease that compromises quality of life of afflicted allogeneic hematopoietic transplantation patients.\n\nA controlled study is necessary to verify findings obtained to date in isolated patients. Currently available ophthalmic solutions and suspensions, drugs and devices largely have not been effective in alleviating the suffering of chronic ocular GvHD patients. Thus, this is an unmet need that Pro-ocular™ topical gel can fulfill.\n\nPotential benefits: Decrease or cessation of adverse ocular symptoms and signs of chronic ocular GvHD, reduction or elimination of the need for other topical ocular therapeutic treatments for chronic ocular GvHD, and restoration of quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female of any race, at least 18 years of age at Visit 1 Screening.\n2. Has the diagnosis of chronic ocular GvHD.\n3. Has an NIH Consensus Eye Score of at least 2.\n4. On the GLIA Ocular Surface Disease Symptoms Questionnaire at Screening, has ocular discomfort at a severity score of moderate or more, and at least one other symptom at a severity of moderate or more.\n5. One or more signs from the list of chronic ocular GvHD signs below\n6. Has provided verbal and written informed consent.\n7. Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.\n\nExclusion Criteria:\n\n1. Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study.\n2. Anticipate major changes in systemic GvHD management during study period.\n3. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to retinal detachment, recent ocular surgery, Bell's palsy, active trigeminal neuritis or trigeminal neuralgia.\n4. Anticipate change of vision correction or anticipate any ocular procedures during study period.\n5. A woman who is pregnant, nursing an infant, or planning a pregnancy.\n6. A woman of childbearing potential who has a positive urine pregnancy test at Visit 1, or who does not use an adequate method of birth control throughout the study period.\n7. Has a known adverse reaction and/or sensitivity to the study drug or its components.\n8. Unwilling to cease the use of sunscreen on the forehead or eye area.\n9. Intraocular pressure \\>22 mm Hg at screening visit with or without ongoing glaucoma treatment.\n10. Currently enrolled in an investigational drug or device study for chronic ocular GvHD."}, 'identificationModule': {'nctId': 'NCT03990051', 'briefTitle': 'Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glia, LLC'}, 'officialTitle': 'Treatment Safety and Efficacy Using Pro-ocular™ 1% for Chronic Ocular Graft-versus-host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation.', 'orgStudyIdInfo': {'id': 'oGvHD-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pro-ocular™', 'description': 'Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.', 'interventionNames': ['Drug: Pro-ocular™ topical gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Vehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.', 'interventionNames': ['Drug: Placebo topical gel']}], 'interventions': [{'name': 'Pro-ocular™ topical gel', 'type': 'DRUG', 'description': 'Topical gel for forehead dermal application', 'armGroupLabels': ['Pro-ocular™']}, {'name': 'Placebo topical gel', 'type': 'DRUG', 'description': 'Topical gel for forehead dermal application', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye and Ear Longwood', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Zhonghui K Luo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Eye and Ear, Longwood'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data may be shared with other investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glia, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}