Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT01646151
Status:
COMPLETED
Last Update Posted:
2014-06-13
First Post:
2012-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary 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': 'D000069580', 'term': 'Bimatoprost'}, {'id': 'C571755', 'term': 'Ganfort'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'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': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs).', 'eventGroups': [{'id': 'EG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.', 'otherNumAtRisk': 2580, 'otherNumAffected': 450, 'seriousNumAtRisk': 2580, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctival Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2580, 'numAffected': 292}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2580, 'numAffected': 158}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2099', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'classes': [{'title': 'Right Eye', 'categories': [{'measurements': [{'value': '20.51', 'spread': '4.32', 'groupId': 'OG000'}]}]}, {'title': 'Left Eye (n=2091)', 'categories': [{'measurements': [{'value': '20.65', 'spread': '4.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.', 'unitOfMeasure': 'Millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with data for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Physician Evaluation of IOP Lowering in the Study Eye(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2375', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '2671', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'classes': [{'title': 'IOP lower than target', 'categories': [{'measurements': [{'value': '622', 'groupId': 'OG000'}]}]}, {'title': 'Target IOP reached', 'categories': [{'measurements': [{'value': '1173', 'groupId': 'OG000'}]}]}, {'title': 'IOP decreased but target not reached', 'categories': [{'measurements': [{'value': '467', 'groupId': 'OG000'}]}]}, {'title': 'IOP increased', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Data Missing', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.", 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All patients with data for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Patient Assessment of Tolerability on a 4-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2347', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '1127', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '1070', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with data for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Physician Assessment of Tolerability on a 4-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2369', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '1212', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '1059', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with data for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Physician Assessment of Patient Compliance Compared to Previous Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'classes': [{'title': 'Better', 'categories': [{'measurements': [{'value': '875', 'groupId': 'OG000'}]}]}, {'title': 'Equal', 'categories': [{'measurements': [{'value': '1151', 'groupId': 'OG000'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with data for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2580', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'description': 'Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2580', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients'}, {'type': 'PRIMARY', 'title': 'IOP at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2099', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'classes': [{'title': 'Right Eye', 'categories': [{'measurements': [{'value': '15.78', 'spread': '2.85', 'groupId': 'OG000'}]}]}, {'title': 'Left Eye (n=2091)', 'categories': [{'measurements': [{'value': '15.87', 'spread': '3.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.', 'unitOfMeasure': 'Millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with data for this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2580'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2410'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2580', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '18 to 30 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '31 to 40 years', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': '41 to 50 years', 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}]}]}, {'title': '51 to 60 years', 'categories': [{'measurements': [{'value': '403', 'groupId': 'BG000'}]}]}, {'title': '61 to 70 years', 'categories': [{'measurements': [{'value': '695', 'groupId': 'BG000'}]}]}, {'title': '71 to 80 years', 'categories': [{'measurements': [{'value': '883', 'groupId': 'BG000'}]}]}, {'title': '81 to 90 years', 'categories': [{'measurements': [{'value': '342', 'groupId': 'BG000'}]}]}, {'title': '>=91 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '1454', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1115', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2580}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2012-07-18', 'resultsFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-15', 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP) at Baseline', 'timeFrame': 'Baseline', 'description': 'IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.'}, {'measure': 'IOP at Week 12', 'timeFrame': 'Week 12', 'description': 'IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.'}], 'secondaryOutcomes': [{'measure': 'Physician Evaluation of IOP Lowering in the Study Eye(s)', 'timeFrame': 'Week 12', 'description': "IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented."}, {'measure': 'Patient Assessment of Tolerability on a 4-Point Scale', 'timeFrame': 'Week 12', 'description': 'Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.'}, {'measure': 'Physician Assessment of Tolerability on a 4-Point Scale', 'timeFrame': 'Week 12', 'description': 'Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.'}, {'measure': 'Physician Assessment of Patient Compliance Compared to Previous Therapy', 'timeFrame': 'Week 12', 'description': 'Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.'}, {'measure': 'Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment', 'timeFrame': '12 Weeks', 'description': 'Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.'}, {'measure': 'Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops', 'timeFrame': 'Week 12', 'description': 'Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with POAG and OHT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of POAG or OHT\n* Previous use of IOP-lowering medication\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01646151', 'briefTitle': 'A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MAF/AGN/OPH/GLA/033'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bimatoprost', 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.', 'interventionNames': ['Drug: Bimatoprost']}], 'interventions': [{'name': 'Bimatoprost', 'type': 'DRUG', 'otherNames': ['LUMIGAN®', 'GANFORT®'], 'description': 'Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.', 'armGroupLabels': ['Bimatoprost']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dresden', 'country': 'Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}