Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-04 @ 3:01 PM
Study NCT ID:
NCT01749904
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2012-12-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With 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': 'C568859', 'term': 'BOL 303259-X'}, {'id': 'D013999', 'term': 'Timolol'}], 'ancestors': [{'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': 'heleen_H_decory@bausch.com', 'phone': '585 732-3284', 'title': 'H. DeCory, Director Medical Affairs', 'organization': 'Bausch + Lomb, a division of Valeant Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \\>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm', 'eventGroups': [{'id': 'EG000', 'title': 'BOL-303259-X', 'description': 'BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase.', 'otherNumAtRisk': 283, 'otherNumAffected': 11, 'seriousNumAtRisk': 283, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Timolol', 'description': 'Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase.', 'otherNumAtRisk': 135, 'otherNumAffected': 3, 'seriousNumAtRisk': 135, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'BOL-303259-X Safety Extension Phase', 'description': 'Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase', 'otherNumAtRisk': 385, 'otherNumAffected': 5, 'seriousNumAtRisk': 385, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 385, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'torn rotator cuff', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Spider bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Recurrence of breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Allergic angioedema due to Motrin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Leg disco-ordination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Right upper lobe lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Fracture of right femoral neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}, {'term': 'Dislocation of intraocular lens', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean IOP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BOL-303259-X', 'description': 'BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).\n\nBOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).\n\nBOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).\n\nTimolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)\n\nBOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}], 'classes': [{'title': '8 am week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.61', 'spread': '3.544', 'groupId': 'OG000'}, {'value': '19.84', 'spread': '3.651', 'groupId': 'OG001'}]}]}, {'title': '12 pm week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.00', 'spread': '3.376', 'groupId': 'OG000'}, {'value': '19.37', 'spread': '3.696', 'groupId': 'OG001'}]}]}, {'title': '4 pm week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.09', 'spread': '3.293', 'groupId': 'OG000'}, {'value': '19.20', 'spread': '3.359', 'groupId': 'OG001'}]}]}, {'title': '8 am week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.59', 'spread': '3.525', 'groupId': 'OG000'}, {'value': '19.63', 'spread': '3.243', 'groupId': 'OG001'}]}]}, {'title': '12 pm week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.84', 'spread': '3.305', 'groupId': 'OG000'}, {'value': '19.09', 'spread': '3.230', 'groupId': 'OG001'}]}]}, {'title': '4 pm week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.82', 'spread': '3.513', 'groupId': 'OG000'}, {'value': '19.09', 'spread': '3.492', 'groupId': 'OG001'}]}]}, {'title': '8 am Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.71', 'spread': '3.382', 'groupId': 'OG000'}, {'value': '19.73', 'spread': '2.230', 'groupId': 'OG001'}]}]}, {'title': '12 pm Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.88', 'spread': '3.409', 'groupId': 'OG000'}, {'value': '19.15', 'spread': '3.311', 'groupId': 'OG001'}]}]}, {'title': '4 pm Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.83', 'spread': '3.521', 'groupId': 'OG000'}, {'value': '19.15', 'spread': '3.643', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol and also superiority of BOL-303259-X to timolol', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \\<1.5 mmHg at all time points of each visit and \\<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\\<0 mmHg at all time points of each visit.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)', 'description': 'Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with LOCF'}, {'type': 'SECONDARY', 'title': 'Response Rate - IOP ≤ 18 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BOL-303259-X', 'description': 'BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).\n\nBOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).\n\nBOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).\n\nTimolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)\n\nBOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).', 'description': 'Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with LOCF'}, {'type': 'SECONDARY', 'title': 'Response Rate - IOP Reduction ≥ 25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BOL-303259-X', 'description': 'BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).\n\nBOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).\n\nBOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).\n\nTimolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)\n\nBOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).', 'description': 'Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with LOCF'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Ocular and Systemic Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BOL-303259-X', 'description': 'BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase.'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase.'}, {'id': 'OG002', 'title': 'BOL-303259-X Safety Extension Phase', 'description': 'Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase'}], 'classes': [{'title': '>/= 1 nonocular AE', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': '>/= 1 ocular (Study eye) AE', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'No statistical analysis was performed on these proportions.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Following assessments through Visit 6 (Month 3), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (analyzed as treated). Of the 420 subjects randomized, 418 instilled at least one dose of study medication and were included in the safety population; one subject randomized to BOL-303259-X received timolol in the efficacy phase and was therefore analyzed as part of the timolol treatment group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BOL-303259-X', 'description': 'BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).\n\nBOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).\n\nBOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}, {'id': 'FG001', 'title': 'Timolol', 'description': 'Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).\n\nTimolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)\n\nBOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'randomized population', 'groupId': 'FG000', 'numSubjects': '286'}, {'comment': 'randomized population', 'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'randomized population', 'groupId': 'FG000', 'numSubjects': '264'}, {'comment': 'randomized population', 'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BOL-303259-X', 'description': 'BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye during the efficacy phase, and for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase'}, {'id': 'BG001', 'title': 'Timolol', 'description': 'Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye. thereafter these subjects were switched to receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '10.32', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '11.23', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '10.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population. Of the 420 subjects randomized, 418 instilled at least one dose of study medication and were included in the safety population, whereas one subject did not have any post-baseline efficacy reading, hence 417 subjects were included in the Intent-to-treat population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2012-12-11', 'resultsFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-10', 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Ocular and Systemic Adverse Events', 'timeFrame': '12 months', 'description': 'Following assessments through Visit 6 (Month 3), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.'}], 'primaryOutcomes': [{'measure': 'Mean IOP', 'timeFrame': '8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)', 'description': 'Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).'}], 'secondaryOutcomes': [{'measure': 'Response Rate - IOP ≤ 18 mm Hg', 'timeFrame': '8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).', 'description': 'Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months'}, {'measure': 'Response Rate - IOP Reduction ≥ 25%', 'timeFrame': '8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).', 'description': 'Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intraocular pressure'], 'conditions': ['Open-Angle Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '26875002', 'type': 'RESULT', 'citation': 'Weinreb RN, Scassellati Sforzolini B, Vittitow J, Liebmann J. Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The APOLLO Study. Ophthalmology. 2016 May;123(5):965-73. doi: 10.1016/j.ophtha.2016.01.019. Epub 2016 Feb 11.'}, {'pmid': '29194198', 'type': 'RESULT', 'citation': 'Weinreb RN, Liebmann JM, Martin KR, Kaufman PL, Vittitow JL. Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings. J Glaucoma. 2018 Jan;27(1):7-15. doi: 10.1097/IJG.0000000000000831.'}]}, 'descriptionModule': {'briefSummary': 'In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes.\n* Participants must meet the following IOP requirements at Visit 3\n* mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye\n* IOP ≤ 36 mmHg at all 3 measurement time points in both eyes.\n* Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye.\n\nExclusion Criteria:\n\n* Participants with known hypersensitivity or contraindications to latanoprost, NO treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs.\n* Participants with a central corneal thickness greater than 600 μm in either eye.\n* Participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.\n* Participants who do not have an intact posterior capsule in either eye .\n* Participants with aphakia in either eye.\n* Participants with previous or active corneal disease in either eye.\n* Participants with current or a history of severe dry eye in either eye.\n* Participants with current or a history of optic disc hemorrhage in either eye.\n* Participants with current or a history of central/branch retinal vein or artery occlusion in either eye.\n* Participants with current or a history of macular edema in either eye.\n* Participants with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and Participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye.\n* Participants with a diagnosis of a clinically significant or progressive retinal disease in either eye.\n* Participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to Visit 1 (Screening).\n* Participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to Visit 1 (Screening).\n* Participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening)."}, 'identificationModule': {'nctId': 'NCT01749904', 'acronym': 'APOLLO', 'briefTitle': 'Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.', 'orgStudyIdInfo': {'id': '769'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOL-303259-X', 'description': 'BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).', 'interventionNames': ['Drug: BOL-303259-X']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol', 'description': 'Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).', 'interventionNames': ['Drug: Timolol', 'Drug: BOL-303259-X']}], 'interventions': [{'name': 'BOL-303259-X', 'type': 'DRUG', 'description': 'Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).', 'armGroupLabels': ['BOL-303259-X']}, {'name': 'Timolol', 'type': 'DRUG', 'description': 'Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)', 'armGroupLabels': ['Timolol']}, {'name': 'BOL-303259-X', 'type': 'DRUG', 'description': 'All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)', 'armGroupLabels': ['BOL-303259-X', 'Timolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Jason Vittitow', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}