Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT05022004
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2021-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C111827', 'term': 'brinzolamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trial@sunpharma.com', 'phone': '2266455645', 'title': 'Head-Clinical Development', 'phoneExt': '5689', 'organization': 'Sun Pharmaceutical Industries Limited'}, 'certainAgreement': {'otherDetails': 'The Sponsor has exclusive rights, including the right of authorship, to all publications concerning Study data and findings. The Institution, the Investigator, and the Co-Investigators are contractually bound not to make any publications, public statements, oral presentations concerning the Study data and findings.\n\nThe Sponsor shall have the sole right to review, use, publish, and disclose any data, information, or results developed without limitation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '7 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'BRIN-20-01', 'description': 'Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks', 'otherNumAtRisk': 297, 'deathsNumAtRisk': 297, 'otherNumAffected': 49, 'seriousNumAtRisk': 297, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Azopt®', 'description': 'Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 38, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Abnormal Sensation in Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Conjunctival Hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Conjunctival Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Conjunctivitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Foreign Body Sensation in Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Ocular Hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Swelling of Eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Instillation Site Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Instillation Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Instillation Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Instillation Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Intraocular Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypercholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Breast Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Respiratory Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}], 'seriousEvents': [{'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 297, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BRIN-20-01', 'description': 'Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks'}, {'id': 'OG001', 'title': 'Azopt®', 'description': 'Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks'}], 'classes': [{'title': 'Baseline- Left Eye 08:00', 'categories': [{'measurements': [{'value': '24.92', 'spread': '2.290', 'groupId': 'OG000'}, {'value': '25.06', 'spread': '2.363', 'groupId': 'OG001'}]}]}, {'title': 'Baseline- Right Eye 08:00', 'categories': [{'measurements': [{'value': '24.87', 'spread': '2.378', 'groupId': 'OG000'}, {'value': '25.12', 'spread': '2.358', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Left Eye 10:00', 'categories': [{'measurements': [{'value': '24.54', 'spread': '2.307', 'groupId': 'OG000'}, {'value': '24.83', 'spread': '2.389', 'groupId': 'OG001'}]}]}, {'title': 'Baeline - Right Eye 10:00', 'categories': [{'measurements': [{'value': '24.52', 'spread': '2.423', 'groupId': 'OG000'}, {'value': '24.90', 'spread': '2.365', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 - Left Eye 08:00', 'categories': [{'measurements': [{'value': '19.87', 'spread': '3.436', 'groupId': 'OG000'}, {'value': '19.56', 'spread': '3.642', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 - Right Eye 08:00', 'categories': [{'measurements': [{'value': '19.81', 'spread': '3.400', 'groupId': 'OG000'}, {'value': '19.62', 'spread': '3.423', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 - Left Eye 10:00', 'categories': [{'measurements': [{'value': '18.87', 'spread': '3.544', 'groupId': 'OG000'}, {'value': '18.39', 'spread': '3.760', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 - Right Eye 10:00', 'categories': [{'measurements': [{'value': '18.69', 'spread': '3.572', 'groupId': 'OG000'}, {'value': '18.47', 'spread': '3.468', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 - Left Eye 08:00', 'categories': [{'measurements': [{'value': '18.86', 'spread': '3.162', 'groupId': 'OG000'}, {'value': '18.91', 'spread': '3.333', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 - Right Eye 08:00', 'categories': [{'measurements': [{'value': '18.87', 'spread': '3.067', 'groupId': 'OG000'}, {'value': '18.99', 'spread': '3.123', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 - Left Eye 10:00', 'categories': [{'measurements': [{'value': '17.76', 'spread': '3.252', 'groupId': 'OG000'}, {'value': '17.73', 'spread': '3.418', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 - Right Eye 10:00', 'categories': [{'measurements': [{'value': '17.71', 'spread': '3.190', 'groupId': 'OG000'}, {'value': '17.70', 'spread': '3.162', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.91', 'estimateComment': 'The reported mean difference represents value for Left Eye at Week 2, 08:00am', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.76', 'estimateComment': 'The reported mean difference represents value for Right Eye at Week 2, 08:00am', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.50', 'estimateComment': 'The reported mean difference represents value for Left Eye at Week 6, 08:00am', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.40', 'estimateComment': 'The reported mean difference represents value for Right Eye at Week 6, 08:00am', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Type of Statistical Test - Therapeutic equivalence. 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