Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-02-24 @ 10:51 AM
Study NCT ID:
NCT01814761
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2013-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Bimatoprost 0.01% in the Clinical Setting
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'}]}}, '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': 'The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)', 'eventGroups': [{'id': 'EG000', 'title': 'Pts With POAG or OH (Previously Treatment Naive)', 'description': 'Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).', 'otherNumAtRisk': 42, 'otherNumAffected': 10, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Pts With POAG or OH (Switched Monotherapy)', 'description': 'Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).', 'otherNumAtRisk': 270, 'otherNumAffected': 16, 'seriousNumAtRisk': 270, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}], 'seriousEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Traumatic Intracranial Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in Intraocular Pressure (IOP) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pts With POAG or OH (Previously Treatment Naive)', 'description': 'Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}, {'id': 'OG001', 'title': 'Pts With POAG or OH (Switched Monotherapy)', 'description': 'Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '18.0', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '3.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (N=34, 240)', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '3.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).', 'unitOfMeasure': 'Millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Discontinue Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pts With POAG or OH (Previously Treatment Naive)', 'description': 'Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}, {'id': 'OG001', 'title': 'Pts With POAG or OH (Switched Monotherapy)', 'description': 'Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'description': 'An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment'}, {'type': 'PRIMARY', 'title': 'Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pts With POAG or OH (Previously Treatment Naive)', 'description': 'Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}, {'id': 'OG001', 'title': 'Pts With POAG or OH (Switched Monotherapy)', 'description': 'Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'description': 'Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment'}, {'type': 'SECONDARY', 'title': 'Overall Percent Change From Baseline in IOP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pts With POAG or OH (Previously Treatment Naive)', 'description': 'Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}, {'id': 'OG001', 'title': 'Pts With POAG or OH (Switched Monotherapy)', 'description': 'Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.25', 'groupId': 'OG000', 'lowerLimit': '-24.8', 'upperLimit': '-13.7'}, {'value': '-13.26', 'groupId': 'OG001', 'lowerLimit': '-15.4', 'upperLimit': '-11.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pts With POAG or OH (Previously Treatment Naive)', 'description': 'Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}, {'id': 'FG001', 'title': 'Pts With POAG or OH (Switched Monotherapy)', 'description': 'Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '270'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '240'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Ocular Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pts With POAG or OH (Previously Treatment Naive)', 'description': 'Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}, {'id': 'BG001', 'title': 'Pts With POAG or OH (Switched Monotherapy)', 'description': 'Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '13.65', 'groupId': 'BG000'}, {'value': '53.4', 'spread': '14.45', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '14.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2013-03-18', 'resultsFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2013-03-18', 'lastUpdatePostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-28', 'studyFirstPostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale', 'timeFrame': '12 Weeks', 'description': 'Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Intraocular Pressure (IOP) in the Study Eye', 'timeFrame': 'Baseline, Week 12', 'description': 'IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).'}, {'measure': 'Percentage of Patients Who Discontinue Due to an Adverse Event', 'timeFrame': '12 Weeks', 'description': 'An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.'}, {'measure': 'Overall Percent Change From Baseline in IOP', 'timeFrame': 'Baseline, Week 12', 'description': 'IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma, Primary Open Angle', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '27633513', 'type': 'DERIVED', 'citation': 'Chen YY, Wang TH, Liu C, Wu KY, Chiu SL, Simonyi S, Lu DW. Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study. BMC Ophthalmol. 2016 Sep 15;16(1):162. doi: 10.1186/s12886-016-0338-6.'}]}, 'descriptionModule': {'briefSummary': 'This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with primary open-angle glaucoma or ocular hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary open-angle glaucoma or ocular hypertension\n* Determined by the treating physician to require treatment with bimatoprost 0.01%.\n\nExclusion Criteria:\n\n* Previous use of Lumigan® 0.01%'}, 'identificationModule': {'nctId': 'NCT01814761', 'acronym': 'APPEAL-Taiwan', 'briefTitle': 'A Study of Bimatoprost 0.01% in the Clinical Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'GMA-AP-EYE-AGN-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pts with POAG or OH (Previously Treatment Naive)', 'description': 'Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).', 'interventionNames': ['Drug: Bimatoprost 0.01%']}, {'label': 'Pts with POAG or OH (Switched Monotherapy)', 'description': 'Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).', 'interventionNames': ['Drug: Bimatoprost 0.01%']}], 'interventions': [{'name': 'Bimatoprost 0.01%', 'type': 'DRUG', 'otherNames': ['Lumigan® 0.01%'], 'description': 'One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.', 'armGroupLabels': ['Pts with POAG or OH (Previously Treatment Naive)', 'Pts with POAG or OH (Switched Monotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}