Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT02247804
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'China', 'France', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009339', 'term': 'Needles'}, {'id': 'D013999', 'term': 'Timolol'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug to last visit (Up to approximately 20 months)', 'description': 'Safety population included all participants who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'otherNumAtRisk': 193, 'deathsNumAtRisk': 193, 'otherNumAffected': 143, 'seriousNumAtRisk': 193, 'deathsNumAffected': 2, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 138, 'seriousNumAtRisk': 197, 'deathsNumAffected': 1, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 105, 'seriousNumAtRisk': 197, 'deathsNumAffected': 1, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 47}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal endothelial cell loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anterior chamber cell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Visual field defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal endothelial cell loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Corneal touch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Post procedural sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rib 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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22.0'}, {'term': 'Prostate cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Trigeminal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'VIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Internal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'title': 'Change from Baseline at Hour 0, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.46', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-6.38', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-6.05', 'spread': '0.28', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Hour 2, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.18', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-6.69', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-6.48', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2950', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.3904', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0464', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.5383', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.', 'unitOfMeasure': 'millimeters of mercury (mm Hg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 2 (Hour 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.82', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '17.02', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '17.83', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0033', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.01', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0187', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '-0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 2 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 2 (Hour 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.48', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '16.42', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '17.33', 'spread': '0.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0057', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-1.45', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0031', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '-0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 2 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 6 (Hour 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.08', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '16.88', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '17.71', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0547', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0107', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '-0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 6 (Hour 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.62', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '16.51', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '17.16', 'spread': '0.23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0860', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0362', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 12 (Hour 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.53', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '17.61', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '17.94', 'spread': '0.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2950', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.3904', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'IOP in the Study Eye at Week 12 (Hour 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.81', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '17.30', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '17.51', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0464', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.5383', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IOP in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'OG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'classes': [{'title': 'Change from Baseline at Hour 0, Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.17', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-6.97', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-6.17', 'spread': '0.25', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Hour 2, Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.52', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-7.57', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '-6.67', 'spread': '0.22', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Hour 0, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.91', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-7.11', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-6.29', 'spread': '0.24', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Hour 2, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.37', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-7.48', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '-6.83', 'spread': '0.23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0033', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.01', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0187', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '-0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0057', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-1.45', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0031', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '-0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0547', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0107', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '-0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0860', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}, {'pValue': '0.0362', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least-squares Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \\< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'FG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'FG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '198'}, {'groupId': 'FG002', 'numSubjects': '198'}]}, {'type': 'Received (Sham or Bimatoprost SR)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '197'}, {'groupId': 'FG002', 'numSubjects': '197'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '194'}, {'groupId': 'FG002', 'numSubjects': '190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'comment': 'Started=received administration (Sham or Bimatoprost SR) in the cycle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '191'}, {'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '186'}, {'groupId': 'FG002', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'comment': 'Started=received administration (Sham or Bimatoprost SR) in the cycle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '183'}, {'groupId': 'FG002', 'numSubjects': '177'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '173'}, {'groupId': 'FG002', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}, {'value': '594', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'BG001', 'title': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'BG002', 'title': 'Timolol 0.5%: Comparator', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '62.5', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '288', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '306', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Hispanic', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intraocular Pressure (IOP)', 'classes': [{'title': 'Hour 0', 'categories': [{'measurements': [{'value': '24.76', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '32.0'}, {'value': '24.64', 'groupId': 'BG001', 'lowerLimit': '21.5', 'upperLimit': '32.0'}, {'value': '24.63', 'groupId': 'BG002', 'lowerLimit': '16.0', 'upperLimit': '32.0'}, {'value': '24.68', 'groupId': 'BG003', 'lowerLimit': '16.0', 'upperLimit': '32.0'}]}]}, {'title': 'Hour 2', 'categories': [{'measurements': [{'value': '23.56', 'groupId': 'BG000', 'lowerLimit': '19.0', 'upperLimit': '32.0'}, {'value': '23.29', 'groupId': 'BG001', 'lowerLimit': '19.0', 'upperLimit': '32.0'}, {'value': '23.19', 'groupId': 'BG002', 'lowerLimit': '16.0', 'upperLimit': '32.0'}, {'value': '23.35', 'groupId': 'BG003', 'lowerLimit': '16.0', 'upperLimit': '32.0'}]}]}], 'paramType': 'MEAN', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Intent-to-treat (ITT) population was defined as all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-19', 'size': 927859, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-03T20:54', 'hasProtocol': False}, {'date': '2017-03-16', 'size': 9312895, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-03T20:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 594}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2019-02-07', 'completionDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2014-09-22', 'dispFirstSubmitQcDate': '2019-02-07', 'resultsFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2014-09-22', 'dispFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-03', 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)', 'timeFrame': 'Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.'}, {'measure': 'IOP in the Study Eye at Week 2 (Hour 0)', 'timeFrame': 'Week 2 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 2 (Hour 2)', 'timeFrame': 'Week 2 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 6 (Hour 0)', 'timeFrame': 'Week 6 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 6 (Hour 2)', 'timeFrame': 'Week 6 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 12 (Hour 0)', 'timeFrame': 'Week 12 (Hour 0)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}, {'measure': 'IOP in the Study Eye at Week 12 (Hour 2)', 'timeFrame': 'Week 12 (Hour 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in IOP in the Study Eye', 'timeFrame': 'Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)', 'description': 'IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '36378864', 'type': 'DERIVED', 'citation': 'Weinreb RN, Bacharach J, Brubaker JW, Medeiros FA, Bejanian M, Bernstein P, Robinson MR. Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):55-62. doi: 10.1089/jop.2022.0137. Epub 2022 Nov 15.'}, {'pmid': '35643967', 'type': 'DERIVED', 'citation': 'Medeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.'}], 'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.\n\nExclusion Criteria:\n\n* Previous enrollment in another Allergan Bimatoprost SR Study.\n* Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye\n* Anticipated need for laser eye surgery in either eye within the first 52 weeks of the study duration\n* History of glaucoma surgery'}, 'identificationModule': {'nctId': 'NCT02247804', 'briefTitle': 'Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': '192024-091'}, 'secondaryIdInfos': [{'id': '2014-003037-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bimatoprost SR 15 μg', 'description': 'Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'interventionNames': ['Drug: Bimatoprost SR', 'Drug: Active Comparator: Timolol 0.5%', 'Other: Sham: Applicator Without Needle', 'Drug: Timolol Vehicle (placebo)']}, {'type': 'EXPERIMENTAL', 'label': 'Bimatoprost SR 10 μg', 'description': 'Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'interventionNames': ['Drug: Bimatoprost SR', 'Drug: Active Comparator: Timolol 0.5%', 'Other: Sham: Applicator Without Needle', 'Drug: Timolol Vehicle (placebo)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol 0.5%', 'description': 'Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'interventionNames': ['Drug: Active Comparator: Timolol 0.5%', 'Other: Sham: Applicator Without Needle']}], 'interventions': [{'name': 'Bimatoprost SR', 'type': 'DRUG', 'otherNames': ['AGN-192024'], 'description': 'Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.', 'armGroupLabels': ['Bimatoprost SR 10 μg', 'Bimatoprost SR 15 μg']}, {'name': 'Active Comparator: Timolol 0.5%', 'type': 'DRUG', 'description': 'Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.', 'armGroupLabels': ['Bimatoprost SR 10 μg', 'Bimatoprost SR 15 μg', 'Timolol 0.5%']}, {'name': 'Sham: Applicator Without Needle', 'type': 'OTHER', 'description': 'Sham administered on Day 1, Week 16, and Week 32.', 'armGroupLabels': ['Bimatoprost SR 10 μg', 'Bimatoprost SR 15 μg', 'Timolol 0.5%']}, {'name': 'Timolol Vehicle (placebo)', 'type': 'DRUG', 'description': 'Timolol vehicle administered once in the morning and once in the evening for up to 20 months.', 'armGroupLabels': ['Bimatoprost SR 10 μg', 'Bimatoprost SR 15 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Glaucoma Specialists', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91205', 'city': 'Glendale', 'state': 'California', 'country': 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