Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-03-03 @ 12:44 AM
Study NCT ID:
NCT02006693
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2013-12-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, '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': {'timeFrame': 'Up to 26 Months', 'description': 'The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.', 'eventGroups': [{'id': 'EG000', 'title': 'XEN® Gel Stent', 'description': 'The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 112, 'otherNumAffected': 14, 'seriousNumAtRisk': 120, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'XEN® Gel Stent With Cataract Surgery', 'description': 'The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 87, 'otherNumAffected': 8, 'seriousNumAtRisk': 98, 'deathsNumAffected': 2, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Hyphema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Trabeculectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'YAG (yttrium-aluminum-garnet) laser surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Heart attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cataract aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Implant site dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Decompensated cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Broken hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intraocular pressure high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intraocular pressure high - fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Kidney tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomach cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Trabeculectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XEN® Gel Stent', 'description': 'The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.'}, {'id': 'OG001', 'title': 'XEN® Gel Stent With Cataract Surgery', 'description': 'The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.'}], 'classes': [{'title': 'Baseline (preoperation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '3.39', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '5.64', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '4.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XEN® Gel Stent', 'description': 'The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.'}, {'id': 'OG001', 'title': 'XEN® Gel Stent With Cataract Surgery', 'description': 'The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.'}], 'classes': [{'title': 'Baseline (preoperation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)', 'description': 'The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in IOP in the Study Eyes to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XEN® Gel Stent', 'description': 'The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.'}, {'id': 'OG001', 'title': 'XEN® Gel Stent With Cataract Surgery', 'description': 'The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.'}], 'classes': [{'title': 'Baseline (preoperation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '3.39', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '4.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XEN® Gel Stent', 'description': 'The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.'}, {'id': 'OG001', 'title': 'XEN® Gel Stent With Cataract Surgery', 'description': 'The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.'}], 'classes': [{'title': 'Baseline (preoperation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)', 'description': 'The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'XEN® Gel Stent', 'description': 'The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.'}, {'id': 'FG001', 'title': 'XEN® Gel Stent With Cataract Surgery', 'description': 'The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '120', 'numSubjects': '112'}, {'groupId': 'FG001', 'numUnits': '98', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '91', 'numSubjects': '84'}, {'groupId': 'FG001', 'numUnits': '83', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '29', 'numSubjects': '28'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'No Reason Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Another Glaucoma-related Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'XEN Implant Explantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'units': 'Eyes', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'XEN® Gel Stent', 'description': 'The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.'}, {'id': 'BG001', 'title': 'XEN® Gel Stent With Cataract Surgery', 'description': 'The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.3', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '76.5', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '71.8', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2013-12-02', 'resultsFirstSubmitDate': '2018-06-29', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-25', 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12', 'timeFrame': 'Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12', 'timeFrame': 'Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)', 'description': 'The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.'}, {'measure': 'Mean Change From Baseline in IOP in the Study Eyes to Month 24', 'timeFrame': 'Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24', 'timeFrame': 'Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)', 'description': 'The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['XEN', 'Primary Open Angle Glaucoma', 'Filtration Device', 'Ab interno'], 'conditions': ['Primary Open Angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '30758653', 'type': 'DERIVED', 'citation': 'Reitsamer H, Sng C, Vera V, Lenzhofer M, Barton K, Stalmans I; Apex Study Group. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996. doi: 10.1007/s00417-019-04251-z. Epub 2019 Feb 13.'}, {'pmid': '29267575', 'type': 'DERIVED', 'citation': 'Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the AqueSys XEN Implant \\[XEN® Gel Stent (XEN45 Implant)\\] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary open angle glaucoma\n* Participants are taking at least one and no more than four topical IOP-lowering medications.\n\nExclusion Criteria:\n\n* Angle Closure Glaucoma\n* Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders\n* Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)\n* Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant'}, 'identificationModule': {'nctId': 'NCT02006693', 'briefTitle': 'Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AqueSys, Inc.'}, 'officialTitle': 'Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects', 'orgStudyIdInfo': {'id': 'MS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'XEN® Gel Stent', 'description': 'The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.', 'interventionNames': ['Device: XEN® Gel Stent']}, {'type': 'OTHER', 'label': 'XEN® Gel Stent with Cataract Surgery', 'description': 'The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.', 'interventionNames': ['Procedure: Cataract Surgery']}], 'interventions': [{'name': 'XEN® Gel Stent', 'type': 'DEVICE', 'otherNames': ['XEN Glaucoma Implant', 'XEN Gel Stent', 'XEN45 Implant'], 'description': 'The XEN® Gel Stent (XEN45 implant) was placed in the study eye.', 'armGroupLabels': ['XEN® Gel Stent']}, {'name': 'Cataract Surgery', 'type': 'PROCEDURE', 'description': 'Participants diagnosed with a cataract elected to have cataract surgery.', 'armGroupLabels': ['XEN® Gel Stent with Cataract Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'University Augenklinik Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Vienna University', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '44892', 'city': 'Bochum', 'country': 'Germany', 'facility': 'University Eye Clinic Bochum-Langendreer', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': 'D-60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinik für Augenheilkunde', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '17036', 'city': 'Neubrandenburg', 'country': 'Germany', 'facility': 'Klinik fur Augenheilkunde', 'geoPoint': {'lat': 53.55735, 'lon': 13.26105}}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'University of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '10100', 'city': 'Torino', 'country': 'Italy', 'facility': "Clinica Oculistica, Universita' di Torino", 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Integrated University Hospital of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '04-141', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Ophthalmology Department of the Military Health Service Institute', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Hospital Meixeiro Servicio de Ofthalmologia', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Principe de Asturias', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital Eye, Ear and Mouth Unit', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'B18 7QH', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Birmingham Midland Eye Theaters', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'EC1V2PD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Moorfields Eye Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE17EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St. Thomas Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WF14DG', 'city': 'Wakefield', 'country': 'United Kingdom', 'facility': 'Pinderfields Hospital', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}, {'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Unidad Oftalmologica de Caracas', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}], 'overallOfficials': [{'name': 'Vanessa Vera, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AqueSys, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}