Viewing Study NCT03652051

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Ignite Creation Date: 2025-12-24 @ 11:39 PM
Ignite Modification Date: 2026-02-25 @ 11:48 PM
Study NCT ID: NCT03652051
Status: COMPLETED
Last Update Posted: 2024-02-28
First Post: 2018-08-27
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charles.bosworth@azuraophthalmics.com', 'phone': '17145598435', 'title': 'Charles Bosworth', 'organization': 'Azura Ophthalmics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: AZR-MD-001 Low Dose', 'description': 'AZR-MD-001 Low Dose was dosed twice weekly.\n\nAZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stage 1: AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 13, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stage 1: AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 14, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Stage 1: AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Stage 2: AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 54, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Stage 2: AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 60, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Stage 2: AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 8, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Application site pain', 'notes': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Lacrimation increased', 'notes': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Punctate keratitis', 'notes': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Vital dye staining cornea present', 'notes': 'Vital dye staining cornea present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Eye pain', 'notes': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Eye irritation', 'notes': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Application site reaction', 'notes': 'Application site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Foreign body sensation', 'notes': 'Foreign body sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Administration site reaction', 'notes': 'Administration site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Photophobia', 'notes': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Eye inflammation', 'notes': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Application site irritation', 'notes': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}], 'seriousEvents': [{'term': 'pneumonia', 'notes': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Pericarditis', 'notes': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Thyroid mass', 'notes': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 80, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Post procedural haemorrhage', 'notes': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 83, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'n intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'ocular toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Meibomian Glands Yielding Liquid Secretion (MGYLS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}, {'value': '80', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: AZR-MD-001 Low Dose', 'description': 'AZR-MD-001 Low Dose was dosed twice weekly.\n\nAZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG001', 'title': 'Stage 1: AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG002', 'title': 'Stage 1: AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG003', 'title': 'Stage 1: AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment'}, {'id': 'OG004', 'title': 'Stage 2: AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG005', 'title': 'Stage 2: AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG006', 'title': 'Stage 2: AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.07', 'spread': '0.81', 'groupId': 'OG002'}, {'value': '1.88', 'spread': '1.38', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '0.36', 'groupId': 'OG004'}, {'value': '3.2', 'spread': '0.4', 'groupId': 'OG005'}, {'value': '2.4', 'spread': '0.34', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Value at month 3 minus value at baseline', 'description': 'Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)', 'unitOfMeasure': 'Number of Open Glands', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ocular Surface Disease Index (OSDI) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '83', 'groupId': 'OG005'}, {'value': '80', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: AZR-MD-001 Low Dose', 'description': 'AZR-MD-001 Low Dose was dosed twice weekly.\n\nAZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG001', 'title': 'Stage 1: AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG002', 'title': 'Stage 1: AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG003', 'title': 'Stage 1: AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment'}, {'id': 'OG004', 'title': 'Stage 2: AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG005', 'title': 'Stage 2: AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'OG006', 'title': 'Stage 2: AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment'}], 'classes': [{'categories': [{'measurements': [{'value': '12.93', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '-8.73', 'spread': '2.37', 'groupId': 'OG001'}, {'value': '-4.74', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '-2.34', 'spread': '4.09', 'groupId': 'OG003'}, {'value': '-7.29', 'spread': '1.3', 'groupId': 'OG004'}, {'value': '-6.1', 'spread': '1.3', 'groupId': 'OG005'}, {'value': '-3.8', 'spread': '1.2', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Value at month 3 minus value at baseline', 'description': 'Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZR-MD-001 Low Dose', 'description': 'AZR-MD-001 Low Dose was dosed twice weekly.\n\nAZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'FG001', 'title': 'AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'FG002', 'title': 'AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'FG003', 'title': 'AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'comment': 'Stage 2 was conducted without including any subjects from Stage 1 to enable Stage 2 to qualify as a confirmatory efficacy study based upon feedback from the FDA at a pre-IND meeting.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}, {'value': '321', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1: AZR-MD-001 Low Dose', 'description': 'AZR-MD-001 Low Dose was dosed twice weekly.\n\nAZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'BG001', 'title': 'Stage 1: AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'BG002', 'title': 'Stage 1: AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'BG003', 'title': 'Stage 1: AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment'}, {'id': 'BG004', 'title': 'Stage 2: AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose was dosed twice weekly.\n\nAZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'BG005', 'title': 'Stage 2: AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose was dosed twice weekly.\n\nAZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment'}, {'id': 'BG006', 'title': 'Stage 2: AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle was dosed twice weekly.\n\nAZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '18.79', 'groupId': 'BG000'}, {'value': '42.1', 'spread': '17.71', 'groupId': 'BG001'}, {'value': '45.6', 'spread': '22.02', 'groupId': 'BG002'}, {'value': '43.6', 'spread': '20.34', 'groupId': 'BG003'}, {'value': '52.1', 'spread': '16.9', 'groupId': 'BG004'}, {'value': '55.6', 'spread': '17.2', 'groupId': 'BG005'}, {'value': '51.9', 'spread': '18.5', 'groupId': 'BG006'}, {'value': '53.2', 'spread': '17.5', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}, {'value': '56', 'groupId': 'BG006'}, {'value': '196', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '125', 'groupId': 'BG007'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}, {'value': '78', 'groupId': 'BG006'}, {'value': '305', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '77', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}, {'value': '56', 'groupId': 'BG006'}, {'value': '217', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Meibomian Glands Yielding Liquid Secretion (Primary Sign Endpoint)', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.58', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '1.26', 'groupId': 'BG001'}, {'value': '2.9', 'spread': '1.49', 'groupId': 'BG002'}, {'value': '2.8', 'spread': '1.64', 'groupId': 'BG003'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'BG004'}, {'value': '1.9', 'spread': '1.4', 'groupId': 'BG005'}, {'value': '1.8', 'spread': '1.3', 'groupId': 'BG006'}, {'value': '1.8', 'spread': '1.3', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'description': 'Count of the number of open glands on the inferior lid ranging from 0 (no open glands) to 15 (total number of evaluated glands)', 'unitOfMeasure': 'Gland Count (0 to 15)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'OSDI Total Score (Primary Symptom Endpoint)', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '7.42', 'groupId': 'BG000'}, {'value': '23.1', 'spread': '6.10', 'groupId': 'BG001'}, {'value': '21.34', 'spread': '4.86', 'groupId': 'BG002'}, {'value': '22.64', 'spread': '7.57', 'groupId': 'BG003'}, {'value': '25.2', 'spread': '7.5', 'groupId': 'BG004'}, {'value': '24.2', 'spread': '6', 'groupId': 'BG005'}, {'value': '25', 'spread': '6.7', 'groupId': 'BG006'}, {'value': '24.8', 'spread': '6.7', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'description': 'The total score on the OSDI ranges from 0 (normal) to 100 (severe disease)', 'unitOfMeasure': 'Total Score (0 to 100)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-19', 'size': 1674066, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-16T18:55', 'hasProtocol': True}, {'date': '2022-04-22', 'size': 1197517, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-16T18:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 321}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2018-08-27', 'resultsFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-14', 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meibomian Glands Yielding Liquid Secretion (MGYLS)', 'timeFrame': 'Value at month 3 minus value at baseline', 'description': 'Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)'}, {'measure': 'Ocular Surface Disease Index (OSDI) Total Score', 'timeFrame': 'Value at month 3 minus value at baseline', 'description': 'Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meibomian Gland Dysfunction', 'Dry Eye']}, 'referencesModule': {'references': [{'pmid': '37478969', 'type': 'DERIVED', 'citation': 'Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, Alster Y, Bosworth C, Rafaeli O, DePuy V; CELESTIAL STUDY Group. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-546. doi: 10.1016/j.jtos.2023.07.002. Epub 2023 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)', 'detailedDescription': 'AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or older\n* Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye\n* Evidence of meibomian gland obstruction\n* Reported dry eye signs and symptoms within the past 3 months\n\nExclusion Criteria:\n\n* Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease\n* Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study\n* Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity\n* BCVA worse than 20/40 in either eye\n* Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye'}, 'identificationModule': {'nctId': 'NCT03652051', 'briefTitle': 'A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azura Ophthalmics'}, 'officialTitle': 'A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye Disease (DED)', 'orgStudyIdInfo': {'id': 'AZ201801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZR-MD-001 Low Dose', 'description': 'AZR-MD-001 Low Dose will be dosed up to once daily.', 'interventionNames': ['Drug: AZR-MD-001 Low Dose']}, {'type': 'EXPERIMENTAL', 'label': 'AZR-MD-001 Mid Dose', 'description': 'AZR-MD-001 Mid Dose will be dosed up to once daily.', 'interventionNames': ['Drug: AZR-MD-001 Mid Dose']}, {'type': 'EXPERIMENTAL', 'label': 'AZR-MD-001 High Dose', 'description': 'AZR-MD-001 High Dose will be dosed up to once daily.', 'interventionNames': ['Drug: AZR-MD-001 High Dose']}, {'type': 'SHAM_COMPARATOR', 'label': 'AZR-MD-001 Vehicle', 'description': 'AZR-MD-001 Vehicle will be dosed up to once daily.', 'interventionNames': ['Drug: AZR-MD-001 Vehicle']}], 'interventions': [{'name': 'AZR-MD-001 Low Dose', 'type': 'DRUG', 'description': 'AZR-MD-001 is an ophthalmic ointment', 'armGroupLabels': ['AZR-MD-001 Low Dose']}, {'name': 'AZR-MD-001 Mid Dose', 'type': 'DRUG', 'description': 'AZR-MD-001 is an ophthalmic ointment', 'armGroupLabels': ['AZR-MD-001 Mid Dose']}, {'name': 'AZR-MD-001 High Dose', 'type': 'DRUG', 'description': 'AZR-MD-001 is an ophthalmic ointment', 'armGroupLabels': ['AZR-MD-001 High Dose']}, {'name': 'AZR-MD-001 Vehicle', 'type': 'DRUG', 'description': 'AZR-MD-001 is a vehicle ophthalmic ointment', 'armGroupLabels': ['AZR-MD-001 Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2067', 'city': 'Chatswood', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Vision Eye Institute', 'geoPoint': {'lat': -33.8, 'lon': 151.18333}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Eye Associates', 'geoPoint': {'lat': -33.86785, 'lon': 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