Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-26 @ 6:48 AM
Study NCT ID:
NCT00905450
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C546413', 'term': 'R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susan.harris@bauschhealth.com', 'title': 'Study Director', 'organization': 'Bausch Health'}, 'certainAgreement': {'otherDetails': 'Contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '18 days', 'eventGroups': [{'id': 'EG000', 'title': '1% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 1% Twice a Day', 'otherNumAtRisk': 60, 'otherNumAffected': 43, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Once a Day', 'otherNumAtRisk': 28, 'otherNumAffected': 20, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '2% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Twice a Day', 'otherNumAtRisk': 28, 'otherNumAffected': 7, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '2% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Four times a Day', 'otherNumAtRisk': 60, 'otherNumAffected': 18, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '3% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Once a Day', 'otherNumAtRisk': 59, 'otherNumAffected': 11, 'seriousNumAtRisk': 59, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': '3% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Twice a Day', 'otherNumAtRisk': 60, 'otherNumAffected': 25, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': '3% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Four times a Day', 'otherNumAtRisk': 60, 'otherNumAffected': 21, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Vehicle', 'description': 'Vehicle for BOL-303242-X ophthalmic suspension', 'otherNumAtRisk': 60, 'otherNumAffected': 37, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'AC Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Corneal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctival hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'AC Flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ciliary hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Cystoid macular edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subretinal neovascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '1% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 1% Twice a Day'}, {'id': 'OG001', 'title': '2% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Once a Day'}, {'id': 'OG002', 'title': '2% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Twice a Day'}, {'id': 'OG003', 'title': '2% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Four times a Day'}, {'id': 'OG004', 'title': '3% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Once a Day'}, {'id': 'OG005', 'title': '3% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Twice a Day'}, {'id': 'OG006', 'title': '3% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Four times a Day'}, {'id': 'OG007', 'title': 'Vehicle', 'description': 'Vehicle for BOL-303242-X ophthalmic suspension'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 days', 'description': 'Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \\>30 cells. Complete resolution of AC cells was defined as Grade 0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '1% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 1% Twice a Day'}, {'id': 'OG001', 'title': '2% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Once a Day'}, {'id': 'OG002', 'title': '2% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Twice a Day'}, {'id': 'OG003', 'title': '2% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Four times a Day'}, {'id': 'OG004', 'title': '3% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Once a Day'}, {'id': 'OG005', 'title': '3% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Twice a Day'}, {'id': 'OG006', 'title': '3% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Four times a Day'}, {'id': 'OG007', 'title': 'Vehicle', 'description': 'Vehicle for BOL-303242-X ophthalmic suspension'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 days', 'description': 'A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution of AC flare was defined as Grade 0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 1% Twice a Day'}, {'id': 'FG001', 'title': '2% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Once a Day'}, {'id': 'FG002', 'title': '2% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Twice a Day'}, {'id': 'FG003', 'title': '2% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Four times a Day'}, {'id': 'FG004', 'title': '3% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Once a Day'}, {'id': 'FG005', 'title': '3% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Twice a Day'}, {'id': 'FG006', 'title': '3% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Four times a Day'}, {'id': 'FG007', 'title': 'Vehicle', 'description': 'Vehicle for BOL-303242-X ophthalmic suspension'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '60'}, {'groupId': 'FG006', 'numSubjects': '60'}, {'groupId': 'FG007', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '58'}, {'groupId': 'FG006', 'numSubjects': '58'}, {'groupId': 'FG007', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '415', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '1% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 1% Twice a Day'}, {'id': 'BG001', 'title': '2% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Once a Day'}, {'id': 'BG002', 'title': '2% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Twice a Day'}, {'id': 'BG003', 'title': '2% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 2% Four times a Day'}, {'id': 'BG004', 'title': '3% Once a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Once a Day'}, {'id': 'BG005', 'title': '3% Twice a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Twice a Day'}, {'id': 'BG006', 'title': '3% Four Times a Day', 'description': 'BOL-303242-X ophthalmic suspension 3% Four times a Day'}, {'id': 'BG007', 'title': 'Vehicle', 'description': 'Vehicle for BOL-303242-X ophthalmic suspension'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '67.9', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '68.9', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '69.5', 'spread': '7.1', 'groupId': 'BG003'}, {'value': '68.2', 'spread': '10.8', 'groupId': 'BG004'}, {'value': '67.3', 'spread': '10.7', 'groupId': 'BG005'}, {'value': '68.5', 'spread': '10.3', 'groupId': 'BG006'}, {'value': '67.1', 'spread': '10.8', 'groupId': 'BG007'}, {'value': '67.8', 'spread': '10.4', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}, {'value': '222', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '193', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 415}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2011-04-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2009-05-19', 'dispFirstSubmitQcDate': '2011-05-04', 'resultsFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2009-05-19', 'dispFirstPostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-18', 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.', 'timeFrame': '8 days', 'description': 'Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \\>30 cells. Complete resolution of AC cells was defined as Grade 0.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.', 'timeFrame': '8 days', 'description': 'A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens will be performed without pupil dilation. Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). The grades for flare were 0=None to 4=Very Severe effect. Complete resolution of AC flare was defined as Grade 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Surgery'], 'conditions': ['Cataract', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.\n* Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.\n* Subjects who are candidates for cataract surgery.\n* Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.\n* Subjects must be able and willing to comply with all treatment and follow- up procedures.\n\nExclusion Criteria:\n\n* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.\n* Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.\n* Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up."}, 'identificationModule': {'nctId': 'NCT00905450', 'briefTitle': 'Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'orgStudyIdInfo': {'id': '588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOL-303242-X', 'description': 'BOL-303242-X (Mapracorat)', 'interventionNames': ['Drug: BOL-303242-X']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle for BOL-303242-X (Mapracorat)', 'interventionNames': ['Drug: Vehicle for BOL-303242-X']}], 'interventions': [{'name': 'BOL-303242-X', 'type': 'DRUG', 'otherNames': ['Mapracorat'], 'description': 'Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.', 'armGroupLabels': ['BOL-303242-X']}, {'name': 'Vehicle for BOL-303242-X', 'type': 'DRUG', 'description': 'Medication instilled into the study eye, subjects randomized to various drug dose schedules.', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Laura Trusso, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}