Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00449956
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2007-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479140', 'term': 'dorzolamide-timolol combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)', 'description': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.', 'otherNumAffected': 36, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Timolol 0.5%', 'description': 'Timolol 0.5%, one drop per dose twice daily to the study eye.', 'otherNumAffected': 12, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Concomitant (Dorzolamide 1.0% / Timolol 0.5%)', 'description': 'Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).', 'otherNumAffected': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Corneal epithelium defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Instillation site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Arteriosclerosis obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)', 'description': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.'}, {'id': 'OG001', 'title': 'Timolol 0.5%', 'description': 'Timolol 0.5%, one drop per dose twice daily to the study eye.'}, {'id': 'OG002', 'title': 'Concomitant (Dorzolamide 1.0% / Timolol 0.5%)', 'description': 'Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.50', 'groupId': 'OG000', 'lowerLimit': '-2.86', 'upperLimit': '-2.15'}, {'value': '-1.82', 'groupId': 'OG001', 'lowerLimit': '-2.33', 'upperLimit': '-1.31'}, {'value': '-2.78', 'groupId': 'OG002', 'lowerLimit': '-3.13', 'upperLimit': '-2.43'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '-0.06', 'estimateComment': 'An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.78', 'estimateComment': 'An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin = 1.2 mmHg'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)', 'description': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.'}, {'id': 'OG001', 'title': 'Timolol 0.5%', 'description': 'Timolol 0.5%, one drop per dose twice daily to the study eye.'}, {'id': 'OG002', 'title': 'Concomitant (Dorzolamide 1.0% / Timolol 0.5%)', 'description': 'Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.99', 'groupId': 'OG000', 'lowerLimit': '-13.69', 'upperLimit': '-10.28'}, {'value': '-8.74', 'groupId': 'OG001', 'lowerLimit': '-11.18', 'upperLimit': '-6.30'}, {'value': '-13.46', 'groupId': 'OG002', 'lowerLimit': '-15.15', 'upperLimit': '-11.77'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 Weeks', 'description': 'Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Last observed value during the 8-week treatment period was used in the FAS.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)', 'description': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.'}, {'id': 'OG001', 'title': 'Timolol 0.5%', 'description': 'Timolol 0.5%, one drop per dose twice daily to the study eye.'}, {'id': 'OG002', 'title': 'Concomitant (Dorzolamide 1.0% / Timolol 0.5%)', 'description': 'Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).'}], 'classes': [{'categories': [{'measurements': [{'value': '23.47', 'groupId': 'OG000', 'lowerLimit': '20.07', 'upperLimit': '26.88'}, {'value': '17.17', 'groupId': 'OG001', 'lowerLimit': '12.29', 'upperLimit': '22.05'}, {'value': '26.75', 'groupId': 'OG002', 'lowerLimit': '23.37', 'upperLimit': '30.12'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Last observed value during the 8-week treatment period was used in the FAS.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)', 'description': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.'}, {'id': 'FG001', 'title': 'Timolol 0.5%', 'description': 'Timolol 0.5%, one drop per dose twice daily to the study eye.'}, {'id': 'FG002', 'title': 'Concomitant (Dorzolamide 1.0% / Timolol 0.5%)', 'description': 'Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '193'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '184'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Phase III.\n\nStudied period: April 9, 2007 (date study therapy started for the first subject) to February 16, 2008 (the last subject's last visit stipulated in study protocol). Study was conducted at 67 clinical sites.", 'preAssignmentDetails': 'Outpatients with primary open angle glaucoma (broad definition) and/or ocular hypertension received 4-week timolol 0.5% monotherapy in the wash-out period before the study randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}, {'value': '474', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)', 'description': 'MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.'}, {'id': 'BG001', 'title': 'Timolol 0.5%', 'description': 'Timolol 0.5%, one drop per dose twice daily to the study eye.'}, {'id': 'BG002', 'title': 'Concomitant (Dorzolamide 1.0% / Timolol 0.5%)', 'description': 'Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '61.3', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '12.7', 'groupId': 'BG002'}, {'value': '62.4', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '244', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Open-angle glaucoma', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}]}]}, {'title': 'Normal-tension glaucoma', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Ocular hypertension', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Intraocular pressure (IOP) at Hour 2', 'classes': [{'categories': [{'measurements': [{'value': '20.54', 'spread': '2.07', 'groupId': 'BG000'}, {'value': '20.23', 'spread': '1.85', 'groupId': 'BG001'}, {'value': '20.38', 'spread': '2.31', 'groupId': 'BG002'}, {'value': '20.42', 'spread': '2.13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 474}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2008-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2007-03-19', 'resultsFirstSubmitDate': '2009-01-23', 'studyFirstSubmitQcDate': '2007-03-19', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-06', 'studyFirstPostDateStruct': {'date': '2007-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks', 'timeFrame': '8 Weeks', 'description': 'Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)'}, {'measure': 'Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)'}]}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '21735753', 'type': 'RESULT', 'citation': 'Kitazawa Y, Araie M; Research Group on MK-0507A. [Double-masked, phase III comparative study of the combination ophthalmic solution of the 1% dorzolamide hydrochloride/0.5% timolol maleate (MK-0507A) in patients with glaucoma and ocular hypertension]. Nippon Ganka Gakkai Zasshi. 2011 Jun;115(6):495-507. Japanese.'}]}, 'descriptionModule': {'briefSummary': 'The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%) with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in patients with glaucoma and ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with glaucoma and ocular hypertension\n\nExclusion Criteria:\n\n* History of ocular surgery within 3 months\n* Administration contradiction to timolol and dorzolamide'}, 'identificationModule': {'nctId': 'NCT00449956', 'briefTitle': 'MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Multicenter, Double-Blind, Active Comparator-controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers', 'orgStudyIdInfo': {'id': '0507A-149'}, 'secondaryIdInfos': [{'id': 'MK0507A-149'}, {'id': '2007_011'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'combination of dorzolamide hydrochloride and timolol maleate', 'interventionNames': ['Drug: dorzolamide hydrochloride (+) timolol maleate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Concomitant use of dorzolamide hydrochloride and timolol maleate', 'interventionNames': ['Drug: Comparator: timolol maleate', 'Drug: Comparator: dorzolamide hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'timolol maleate', 'interventionNames': ['Drug: Comparator: timolol maleate']}], 'interventions': [{'name': 'dorzolamide hydrochloride (+) timolol maleate', 'type': 'DRUG', 'description': 'Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week', 'armGroupLabels': ['1']}, {'name': 'Comparator: timolol maleate', 'type': 'DRUG', 'description': 'timolol maleate 0.5%, 8-week', 'armGroupLabels': ['2', '3']}, {'name': 'Comparator: dorzolamide hydrochloride', 'type': 'DRUG', 'description': 'dorzolamide hydrochloride 1%, 8-week', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}