Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT01254604
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2010-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Investigator may publish results for his/her study site after publication of results of entire multicenter trial, or after public disclosure of the results online if a multicenter manuscript is not planned. Sponsor must be able to review all proposed results communications regarding study 60 days prior to submission for publication/presentation. Information identified by the Sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after Week 4 visit', 'eventGroups': [{'id': 'EG000', 'title': 'Tafluprost', 'description': 'One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.', 'otherNumAtRisk': 93, 'otherNumAffected': 19, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Timolol', 'description': 'One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.', 'otherNumAtRisk': 94, 'otherNumAffected': 15, 'seriousNumAtRisk': 94, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tafluprost', 'description': 'One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.3', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '-7.6'}, {'value': '-6.6', 'groupId': 'OG001', 'lowerLimit': '-7.3', 'upperLimit': '-5.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '-0.7', 'estimateComment': 'Difference is tafluprost - timolol', 'groupDescription': 'The study hypothesis was that tafluprost is non-inferior to timolol with respect to change from baseline in diurnal IOP at Week 4 in participants with open-angle glaucoma or ocular hypertension. The study hypothesis would be met if the upper bound of the two-sided 95% confidence interval for the between-treatment difference in mean diurnal IOP change from baseline at Week4 (tafluprost - timolol) was ≤1.5 mmHg.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Analysis model includes terms for treatment, baseline IOP and ocular diagnosis (open-angle glaucoma or ocular hypertension)', 'nonInferiorityComment': 'The study was planned to enroll 248 subjects (124 per treatment group) to yield approximately 230 evaluable subjects (115 per treatment group). The study had power of 90% to test the primary hypothesis. The power and sample size were based on the following assumptions for treatment difference in change from baseline in IOP at Week 4: α = 0.025 (1-sided), Non-inferiority margin = 1.5 mmHg, True treatment difference = 0 mmHg, Standard deviation = 3.5 mmHg.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by \\>2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis for this primary efficacy outcome measure. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Change from baseline in IOP at Week 4 = Week 4 IOP value - baseline IOP value.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tafluprost', 'description': 'One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.5', 'ciLowerLimit': '5.7', 'ciUpperLimit': '33.4', 'estimateComment': 'Between-group difference in percentage of participants with ≥25% reduction in IOP at Week 4 = percentage (tafluprost) - percentage (timolol)', 'statisticalMethod': 'Stratified Miettinen and Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Participants were stratified by baseline IOP (\\<26 mmHg or ≥26 mmHg at 0800 hours) and ocular diagnosis (open-angle glaucoma or ocular hypertension)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 4', 'description': 'IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by \\>2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Percent reduction in IOP at Week 4 = (\\[baseline IOP value - Week 4 IOP value\\]/Baseline IOP value)\\*100.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tafluprost', 'description': 'One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '9.4', 'estimateComment': 'Between-group difference in percentage of participants with an AE = percentage (tafluprost) - percentage (timolol)', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after Week 4 visit', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tafluprost', 'description': 'One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.'}, {'id': 'OG001', 'title': 'Timolol', 'description': 'One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '5.7', 'estimateComment': 'Between-group difference in percentage of participants discontinued study drug due to an AE = percentage (tafluprost) - percentage (timolol)', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 4', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tafluprost', 'description': 'One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.'}, {'id': 'FG001', 'title': 'Timolol', 'description': 'One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'Treated', 'achievements': [{'comment': 'The 2 out of 95 started who did not take study drug discontinued due to "Withdrawal by Subject"', 'groupId': 'FG000', 'numSubjects': '93'}, {'comment': 'The 1 out of 95 started who did not take study drug discontinued due to "Withdrawal by Subject"', 'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tafluprost', 'description': 'One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.'}, {'id': 'BG001', 'title': 'Timolol', 'description': 'One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '11.54', 'groupId': 'BG000'}, {'value': '54.9', 'spread': '13.42', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '12.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intraocular Pressure (IOP) - Study Eye', 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '24.9', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '24.9', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline IOP was measured at 0800, 1000 and 1600 hours; 2 values obtained at each time. If the 2 values differed by ≤2 mmHg, average of 2 was recorded; if by \\>2 mmHg, a 3rd measurement was made and median of 3 was recorded. Baseline IOP was mean of the values recorded at the 3 time points. One "study eye" was identified, which was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Data are for "Per Protocol" population: N=84, 84 and 168 for tafluprost, timolol and Total groups, respectively.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All Participants as Treated (APaT) population: All randomized participants who received at least one dose of study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2013-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2010-12-03', 'resultsFirstSubmitDate': '2014-04-09', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-09', 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye', 'timeFrame': 'Baseline and Week 4', 'description': 'IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by \\>2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis for this primary efficacy outcome measure. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Change from baseline in IOP at Week 4 = Week 4 IOP value - baseline IOP value.'}, {'measure': 'Number of Participants With an Adverse Event (AE)', 'timeFrame': 'Up to 14 days after Week 4 visit', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to an AE', 'timeFrame': 'Up to Week 4', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye', 'timeFrame': 'Baseline and Week 4', 'description': 'IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by \\>2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Percent reduction in IOP at Week 4 = (\\[baseline IOP value - Week 4 IOP value\\]/Baseline IOP value)\\*100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tafluprost', 'Glaucoma', 'Ocular Hypertension', 'Timolol', 'Eye Disorder', 'Preservative-Free', 'Prostaglandin Analogue'], 'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=2452-002&kw=2452-002&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '27292765', 'type': 'RESULT', 'citation': 'Chabi A, Baranak C, Lupinacci R, Herring WJ. Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial. Int J Clin Pract. 2016 Jul;70(7):577-86. doi: 10.1111/ijcp.12815. Epub 2016 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'This study will test the hypothesis that preservative-free tafluprost (MK-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension\n* Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)\n* Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)\n* Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye\n* Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing\n* Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications\n* Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study\n* Able to refrigerate study drug at home.\n\nExclusion Criteria:\n\n* Mean IOP \\>36 mmHg in either eye at screening\n* Unable to use study medication in the affected eye(s)\n* History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening\n* History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease\n* Significant visual field loss or evidence of progressive visual loss within the last year\n* Intraocular surgery in either eye in the last 4 months\n* Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye\n* Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)\n* Previously used tafluprost\n* History of cardiovascular disorder within 6 months of screening\n* History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.'}, 'identificationModule': {'nctId': 'NCT01254604', 'briefTitle': 'Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Randomized, Active Comparator-Controlled, Four-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK-2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma or Ocular Hypertension in India', 'orgStudyIdInfo': {'id': '2452-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tafluprost', 'description': 'One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm.', 'interventionNames': ['Drug: Preservative-Free Tafluprost or vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol', 'description': 'One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.', 'interventionNames': ['Drug: Preservative-Free Timolol maleate']}], 'interventions': [{'name': 'Preservative-Free Tafluprost or vehicle', 'type': 'DRUG', 'otherNames': ['MK-2452'], 'description': 'Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug)', 'armGroupLabels': ['Tafluprost']}, {'name': 'Preservative-Free Timolol maleate', 'type': 'DRUG', 'otherNames': ['Preservative-Free Timoptic'], 'description': 'Preservative-free timolol maleate (0.5%) ophthalmic solution', 'armGroupLabels': ['Timolol']}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}