Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-07 @ 6:52 AM
Study NCT ID:
NCT00457795
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2007-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
24-hour IOP-lowering Effect of Brimonidine 0.1%
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': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'Brimonidine 0.1%', 'description': 'Brimonidine 0.1%', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) for a 24-Hour Period at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine 0.1%', 'description': 'Brimonidine 0.1%'}], 'classes': [{'title': 'Diurnal IOP Sitting at Week 4', 'categories': [{'measurements': [{'value': '16.8', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Diurnal IOP Supine at Week 4', 'categories': [{'measurements': [{'value': '21.1', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Nocturnal IOP Supine at Week 4', 'categories': [{'measurements': [{'value': '23.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat defined as all patients who started the study (randomized)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine 0.1%', 'description': 'Brimonidine 0.1%'}], 'classes': [{'title': 'Diurnal IOP Sitting at Baseline', 'categories': [{'measurements': [{'value': '19.2', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Diurnal IOP Supine at Baseline', 'categories': [{'measurements': [{'value': '23.1', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Nocturnal IOP Supine at Baseline', 'categories': [{'measurements': [{'value': '22.7', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Diurnal IOP Sitting Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Diurnal IOP Supine Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Nocturnal IOP Supine Change from Baseline at Wk 4', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat defined as all patients who started the study (randomized)'}, {'type': 'SECONDARY', 'title': 'Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine 0.1%', 'description': 'Brimonidine 0.1%'}], 'classes': [{'title': 'Diurnal OPP Sitting at Week 4', 'categories': [{'measurements': [{'value': '46.8', 'spread': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Diurnal OPP Supine at Week 4', 'categories': [{'measurements': [{'value': '53.8', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Nocturnal OPP Supine at Week 4', 'categories': [{'measurements': [{'value': '49.2', 'spread': '11.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat defined as all patients who started the study (randomized)'}, {'type': 'SECONDARY', 'title': 'Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine 0.1%', 'description': 'Brimonidine 0.1%'}], 'classes': [{'title': 'Diurnal Change in OPP Sitting at Week 4', 'categories': [{'measurements': [{'value': '1.1', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Diurnal Change in OPP Supine at Week 4', 'categories': [{'measurements': [{'value': '0.3', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Nocturnal Change in OPP Supine at Week 4', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat defined as all patients who started the study (randomized)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brimonidine 0.1%', 'description': 'Brimonidine 0.1%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brimonidine 0.1%', 'description': 'Brimonidine 0.1%'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-18', 'studyFirstSubmitDate': '2007-04-06', 'resultsFirstSubmitDate': '2011-10-18', 'studyFirstSubmitQcDate': '2007-04-06', 'lastUpdatePostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-18', 'studyFirstPostDateStruct': {'date': '2007-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP) for a 24-Hour Period at Week 4', 'timeFrame': 'Week 4', 'description': 'IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.'}, {'measure': 'Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4', 'timeFrame': 'Week 4', 'description': 'Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.'}, {'measure': 'Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4', 'timeFrame': 'Week 4', 'description': 'Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.'}]}, 'conditionsModule': {'conditions': ['Open-angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with open-angle glaucoma or ocular hypertension\n\nExclusion Criteria:\n\n* allergy to brimonidine\n* inability to complete 24 hour stay for monitoring'}, 'identificationModule': {'nctId': 'NCT00457795', 'briefTitle': '24-hour IOP-lowering Effect of Brimonidine 0.1%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MA-080806-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'brimonidine 0.1%', 'description': 'brimonidine 0.1%', 'interventionNames': ['Drug: brimonidine 0.1% (Alphagan® P)']}], 'interventions': [{'name': 'brimonidine 0.1% (Alphagan® P)', 'type': 'DRUG', 'otherNames': ['Alphagan® P'], 'description': 'Brimonidine 0.1%, 1 drop three-times daily for 4 weeks', 'armGroupLabels': ['brimonidine 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Medical Affairs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}