Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT01175902
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2010-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057066', 'term': 'Low Tension Glaucoma'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479140', 'term': 'dorzolamide-timolol combination'}, {'id': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ckpark@catholic.ac.kr', 'phone': '82222586208', 'title': 'Chan Kee Park', 'organization': "Seoul St. Mary's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the 12 weeks study period', 'eventGroups': [{'id': 'EG000', 'title': 'Latanoprost', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dorzolamide/Timolol', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP), Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Latanoprost, Period 1', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'OG001', 'title': 'Dorzolamide/Timolol, Period 1', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}], 'classes': [{'title': 'IOP at 8am', 'categories': [{'measurements': [{'value': '13.72', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '13.50', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': 'IOP at 10am', 'categories': [{'measurements': [{'value': '13.27', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '13.36', 'spread': '2.75', 'groupId': 'OG001'}]}]}, {'title': 'IOP at 12pm', 'categories': [{'measurements': [{'value': '13.54', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '12.63', 'spread': '2.98', 'groupId': 'OG001'}]}]}, {'title': 'IOP at 16pm', 'categories': [{'measurements': [{'value': '13.77', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '13.77', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'IOP at 20pm', 'categories': [{'measurements': [{'value': '13.36', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '13.63', 'spread': '2.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.9', 'pValueComment': 'Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.', 'estimateComment': 'Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.', 'groupDescription': 'Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To prove the non-inferiority of Cosopt to Xalatan, the sample size calculation was based on the assumption that non-inferiority margin of trough IOP of 1.5mmHg. A sample size of n=21 patients per group, this study has 80% power (1-β=0.80) and α=0.05, crossover-designed analysis.\n\nIn this study, the upper limit of the 95% CI is expected above the maximal acceptable clinically significant difference of 1.5 mmHg of IOP.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'IOP (mean IOP) after 4 weeks of treatment', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP), Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Latanoprost, Period 2', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'OG001', 'title': 'Dorzolamide/Timolol, Period 2', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}], 'classes': [{'title': 'IOP at 8am', 'categories': [{'measurements': [{'value': '13.13', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '12.36', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'IOP at 10am', 'categories': [{'measurements': [{'value': '12.81', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '12.36', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'IOP at 12pm', 'categories': [{'measurements': [{'value': '12.54', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '12.72', 'spread': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'IOP at 16pm', 'categories': [{'measurements': [{'value': '12.81', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '13.04', 'spread': '2.41', 'groupId': 'OG001'}]}]}, {'title': 'IOP at 20pm', 'categories': [{'measurements': [{'value': '13.40', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '13.13', 'spread': '2.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'IOP (mean IOP) after treaemt from week 8 to week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Pressure (BP), Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Latanoprost, Period 1', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'OG001', 'title': 'Dorzolamide/Timolol, Period 1', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}], 'classes': [{'title': 'systolic BP at 8am', 'categories': [{'measurements': [{'value': '121.82', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '122.82', 'spread': '17.90', 'groupId': 'OG001'}]}]}, {'title': 'systolic BP at 10am', 'categories': [{'measurements': [{'value': '120.68', 'spread': '12.76', 'groupId': 'OG000'}, {'value': '119.14', 'spread': '18.01', 'groupId': 'OG001'}]}]}, {'title': 'systolic BP at 12pm', 'categories': [{'measurements': [{'value': '120.45', 'spread': '13.22', 'groupId': 'OG000'}, {'value': '120.55', 'spread': '17.23', 'groupId': 'OG001'}]}]}, {'title': 'systolic BP at 16pm', 'categories': [{'measurements': [{'value': '122.09', 'spread': '13.14', 'groupId': 'OG000'}, {'value': '118.55', 'spread': '18.74', 'groupId': 'OG001'}]}]}, {'title': 'systolic BP at 20pm', 'categories': [{'measurements': [{'value': '123.32', 'spread': '14.09', 'groupId': 'OG000'}, {'value': '119.45', 'spread': '18.92', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 8am', 'categories': [{'measurements': [{'value': '74.77', 'spread': '11.45', 'groupId': 'OG000'}, {'value': '77.36', 'spread': '8.59', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 10am', 'categories': [{'measurements': [{'value': '74.50', 'spread': '11.13', 'groupId': 'OG000'}, {'value': '73.81', 'spread': '7.32', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 12pm', 'categories': [{'measurements': [{'value': '74.22', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '73.18', 'spread': '7.53', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 16pm', 'categories': [{'measurements': [{'value': '75.27', 'spread': '10.35', 'groupId': 'OG000'}, {'value': '72.81', 'spread': '6.94', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 20pm', 'categories': [{'measurements': [{'value': '75.95', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '74.13', 'spread': '7.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'systolic and diastolic BP at 4 weeks after use of eyedrops', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Pressure (BP), Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Latanoprost, Period 2', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'OG001', 'title': 'Dorzolamide/Timolol, Period 2', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}], 'classes': [{'title': 'systolic BP at 8am', 'categories': [{'measurements': [{'value': '123.14', 'spread': '12.58', 'groupId': 'OG000'}, {'value': '118.41', 'spread': '15.47', 'groupId': 'OG001'}]}]}, {'title': 'systolic BP at 10am', 'categories': [{'measurements': [{'value': '123.59', 'spread': '12.06', 'groupId': 'OG000'}, {'value': '117.95', 'spread': '12.73', 'groupId': 'OG001'}]}]}, {'title': 'systolic BP at 12pm', 'categories': [{'measurements': [{'value': '122.41', 'spread': '11.89', 'groupId': 'OG000'}, {'value': '119.05', 'spread': '13.999', 'groupId': 'OG001'}]}]}, {'title': 'systolic BP at 16pm', 'categories': [{'measurements': [{'value': '124.50', 'spread': '12.78', 'groupId': 'OG000'}, {'value': '118.45', 'spread': '14.90', 'groupId': 'OG001'}]}]}, {'title': 'systolic BP at 20pm', 'categories': [{'measurements': [{'value': '123.23', 'spread': '14.88', 'groupId': 'OG000'}, {'value': '119.82', 'spread': '13.34', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 8am', 'categories': [{'measurements': [{'value': '76.45', 'spread': '7.71', 'groupId': 'OG000'}, {'value': '73.72', 'spread': '9.67', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 10am', 'categories': [{'measurements': [{'value': '74.86', 'spread': '8.40', 'groupId': 'OG000'}, {'value': '72.50', 'spread': '7.70', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 12pm', 'categories': [{'measurements': [{'value': '75.54', 'spread': '7.89', 'groupId': 'OG000'}, {'value': '72.40', 'spread': '8.39', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 16pm', 'categories': [{'measurements': [{'value': '73.45', 'spread': '7.50', 'groupId': 'OG000'}, {'value': '71.36', 'spread': '8.78', 'groupId': 'OG001'}]}]}, {'title': 'diastolic BP at 20pm', 'categories': [{'measurements': [{'value': '73.81', 'spread': '8.64', 'groupId': 'OG000'}, {'value': '74.72', 'spread': '7.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'systolic and diastolic BP measured after treaemt from week 8 to week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Perfusion Pressure (OPP), Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Latanoprost, Period 1', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'OG001', 'title': 'Dorzolamide/Timolol, Period 1', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}], 'classes': [{'title': 'OPP at 8am', 'categories': [{'measurements': [{'value': '46.57', 'spread': '8.34', 'groupId': 'OG000'}, {'value': '49.12', 'spread': '6.76', 'groupId': 'OG001'}]}]}, {'title': 'OPP at 10am', 'categories': [{'measurements': [{'value': '46.65', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '46.95', 'spread': '6.06', 'groupId': 'OG001'}]}]}, {'title': 'OPP at 12pm', 'categories': [{'measurements': [{'value': '46.21', 'spread': '6.64', 'groupId': 'OG000'}, {'value': '48.17', 'spread': '5.51', 'groupId': 'OG001'}]}]}, {'title': 'OPP at 16pm', 'categories': [{'measurements': [{'value': '46.81', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '45.44', 'spread': '5.98', 'groupId': 'OG001'}]}]}, {'title': 'OPP at 20pm', 'categories': [{'measurements': [{'value': '47.79', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '46.73', 'spread': '6.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'OPP was calculated according to the following formula:\n\nOPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'OPP, Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Latanoprost, Period 2', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'OG001', 'title': 'Dorzolamide/Timolol, Period 2', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}], 'classes': [{'title': 'OPP at 8am', 'categories': [{'measurements': [{'value': '48.36', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '46.71', 'spread': '7.34', 'groupId': 'OG001'}]}]}, {'title': 'OPP at 10am', 'categories': [{'measurements': [{'value': '48.04', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '46.07', 'spread': '5.96', 'groupId': 'OG001'}]}]}, {'title': 'OPP at 12pm', 'categories': [{'measurements': [{'value': '48.47', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '45.90', 'spread': '6.00', 'groupId': 'OG001'}]}]}, {'title': 'OPP at 16pm', 'categories': [{'measurements': [{'value': '47.81', 'spread': '6.21', 'groupId': 'OG000'}, {'value': '44.99', 'spread': '5.80', 'groupId': 'OG001'}]}]}, {'title': 'OPP at 20pm', 'categories': [{'measurements': [{'value': '47.10', 'spread': '6.70', 'groupId': 'OG000'}, {'value': '46.70', 'spread': '5.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'OPP was calculated according to the following formula:\n\nOPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP\n\nOPP after treaemt from week 8 to week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Latanoprost', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'FG001', 'title': 'Dorzolamide/Timolol', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Seoul St. Mary's Hospital From April, 5th, 2011 to October, 16th, 2014", 'preAssignmentDetails': '44 enrolled, 44 completed'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Latanoprost', 'description': 'Patients on Latanoprost eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'BG001', 'title': 'Dorzolamide/Timolol', 'description': 'Patients on Dorzolamide/Timolol eyedrops\n\ndorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day\n\nlatanoprost: compare with Cosopt one time a day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.72', 'spread': '7.42', 'groupId': 'BG000'}, {'value': '59.68', 'spread': '7.12', 'groupId': 'BG001'}, {'value': '60.20', 'spread': '7.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Spherical equivalent', 'classes': [{'categories': [{'measurements': [{'value': '-0.74', 'spread': '1.95', 'groupId': 'BG000'}, {'value': '-1.04', 'spread': '2.71', 'groupId': 'BG001'}, {'value': '-0.89', 'spread': '2.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sperical equvalaent comes from refractive error of the patient and it is calcaulated as the algebraic sum of the value of the sphere and half the cylindrical value.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Central corneal thickness', 'classes': [{'categories': [{'measurements': [{'value': '542.73', 'spread': '11.43', 'groupId': 'BG000'}, {'value': '544.23', 'spread': '17.33', 'groupId': 'BG001'}, {'value': '543.48', 'spread': '14.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'micrometers', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean deviation of visual field', 'classes': [{'categories': [{'measurements': [{'value': '-4.00', 'spread': '3.79', 'groupId': 'BG000'}, {'value': '-2.92', 'spread': '2.96', 'groupId': 'BG001'}, {'value': '-3.46', 'spread': '3.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'decibels', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2010-07-26', 'resultsFirstSubmitDate': '2014-11-26', 'studyFirstSubmitQcDate': '2010-08-04', 'lastUpdatePostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-09', 'studyFirstPostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP), Period 1', 'timeFrame': '4 weeks', 'description': 'IOP (mean IOP) after 4 weeks of treatment'}, {'measure': 'Intraocular Pressure (IOP), Period 2', 'timeFrame': '12 weeks', 'description': 'IOP (mean IOP) after treaemt from week 8 to week 12'}, {'measure': 'Blood Pressure (BP), Period 1', 'timeFrame': '4 weeks', 'description': 'systolic and diastolic BP at 4 weeks after use of eyedrops'}, {'measure': 'Blood Pressure (BP), Period 2', 'timeFrame': '12 weeks', 'description': 'systolic and diastolic BP measured after treaemt from week 8 to week 12'}], 'secondaryOutcomes': [{'measure': 'Ocular Perfusion Pressure (OPP), Period 1', 'timeFrame': '4 weeks', 'description': 'OPP was calculated according to the following formula:\n\nOPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP'}, {'measure': 'OPP, Period 2', 'timeFrame': '12 weeks', 'description': 'OPP was calculated according to the following formula:\n\nOPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP\n\nOPP after treaemt from week 8 to week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Normal tension glaucoma'], 'conditions': ['Normal Tension Glaucoma']}, 'referencesModule': {'references': [{'pmid': '26756747', 'type': 'DERIVED', 'citation': 'Lee NY, Park HY, Park CK. Comparison of the Effects of Dorzolamide/Timolol Fixed Combination versus Latanoprost on Intraocular Pressure and Ocular Perfusion Pressure in Patients with Normal-Tension Glaucoma: A Randomized, Crossover Clinical Trial. PLoS One. 2016 Jan 12;11(1):e0146680. doi: 10.1371/journal.pone.0146680. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'To prove the non-inferiority of the fixed timolol-dorzolamide combination (Cosopt) compared to 0.005% latanoprost (Xalatan) in the aspects of intraocular pressure (IOP) and ocular perfusion pressure (OPP) in subjects with normal tension glaucoma (NTG)\n\nClinical hypotheses. Primary hypothesis\n\n* Cosopt group is non-inferior to Xalatan group in diurnal IOP reduction.\n\nSecondary hypothesis\n\n* Cosopt group is non-inferior to Xalatan group in diurnal diastolic and systolic OPP.', 'detailedDescription': "Cosopt (dorzolamide/timolol fixed combination) has well known effect for IOP reduction in POAG and OHT.3-5 However, there is no study about the effect and safety of Cosopt in NTG, Cosopt is not used the first line drug in the management of NTG.\n\nIn Korea, the prevalence of NTG is higher than western countries, the majority (about 80-90%) of open angle glaucoma patients have an IOP of 21 mmHg or less, so the study of NTG is important and searching of effective drug for the treatment of NTG is necessary.\n\nIn this study, we would prove the non-inferiority of Cosopt compared to Xalatan,6 which is used as a first line drug in the management of NTG, in the aspects of IOP and OPP including diastolic OPP (DOPP).\n\nA prospective, interventional, randomized, crossover, single masked, single center study. Forty-four NTG patients were randomly allocated to one of two groups. Patients in group A were treated with Cosopt, lubricant, and Xalatan for 4 weeks each, whereas patients in group B were treated with Xalatan, lubricant, and Cosopt for 4 weeks each.\n\nRecruit NTG patients, who are not treated with the glaucoma medication recent 2 months. If treated, after washout period of 4 weeks, the patients can be included in the study. Baseline IOP, systolic and diastolic BP will be measured. (Day 1) After 4 weeks of treatment of Cosopt or Xalatan, all participants will be checked diurnal IOP, systolic and diastolic BP. IOP was measured by Goldmann applanation tonometry (mean of three consecutive readings) with the patient in a sitting position at the slit lamp. Every IOP will be measured by one masked glaucoma specialist who is unaware of the treatment assignments. After the IOP measurements, after a 5-minite rest, pulse rate and BP (systolic and diastolic) of radial artery were measured in the sitting position using a standard automated blood pressure cuff. During the period, all measuring instruments keep to be calibrated by the manufacturer's instruction.\n\n\\- OPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP. During the 4 weeks washout period, subjects will use lubricants.(Week 8) In this crossover study, with the other eye drops, the same measurement will be performed. (Week 12)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The identification of NTG was based on reproducible glaucomatous visual field defects, corresponding to typical ONH changes.\n\nUnilateral or bilateral visual field loss (description as below) as determined by at least two consecutive automated static threshold perimetry tests.\n\nOne eye is randomly selected in the cases where both eyes are treated.\n\nInclusion criteria:\n\n1. age ranging from 45 to 75 years\n2. best-corrected visual acuity no worse than 20/30 Snellen equivalent\n3. optic nerve head cupping (i.e., a vertical cup-to-disc ratio of more than 0.6) and/or notching of neuroretinal rim, and/or retinal nerve fiber defects characteristic of glaucoma\n4. visual field loss (i.e., a localized defect with at least three adjacent nonedge points depressed \\>5 dB from the normal value, and a nucleus of at least one point depressed 10 dB from the normal value)\n5. repeated measurements of untreated IOP, which documented values less than 22 mmHg\n6. central corneal thickness ranging from 540 to 560 microns\n7. open-angle confirmed by gonioscopy\n\nExclusion criteria:\n\n1. active or chronic systemic diseases and/or concomitant assumption of any medication known to affect IOP, BP and/or HR\n2. corneal abnormalities preventing reliable applanation tonometry\n3. severe ocular trauma, ocular inflammation or infection, intraocular surgery or argon laser treatment or laser trabeculoplasty\n4. myopic or other fundus changes preventing reliable optic disc evaluation,\n5. visual field defects caused by nonglaucomatous disease\n6. history of allergy to the ingredients of Cosopt or Xalatan eye drops'}, 'identificationModule': {'nctId': 'NCT01175902', 'briefTitle': 'Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'To Prove the Non-inferiority of Cosopt Compared to Xalatan in the Aspects of Intraocular Pressure and Ocular Perfusion Pressure in Subjects With Normal Tension Glaucoma', 'orgStudyIdInfo': {'id': 'cosopt-IOP/OPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Latanoprost first, then Dorzolamide/Timolol Patients first on Latanoprost eyedrops once a day, then on Dorzolamide/Timolol twice a day', 'interventionNames': ['Drug: dorzolamide/timolol', 'Drug: latanoprost']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Dorzolamide/Timolol first, then Latanoprost Patients first on Dorzolamide/Timolol eyedrops twice a day, then on Latanoprost eyedrops once a day', 'interventionNames': ['Drug: dorzolamide/timolol', 'Drug: latanoprost']}], 'interventions': [{'name': 'dorzolamide/timolol', 'type': 'DRUG', 'otherNames': ['Cosopt'], 'description': 'dorzolamide/timolol fixed combination eyedrop, 2 times a day', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'latanoprost', 'type': 'DRUG', 'otherNames': ['Xalatan'], 'description': 'compare with dorzolamide/timolol fixed combination eyedrop one time a day', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-070', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chan Kee Park, M.D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic University of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'collaborators': [{'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Seoul St. Mary's Hospital", 'investigatorFullName': 'Chan Kee Park', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}