Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 9:02 AM
Study NCT ID:
NCT01166659
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2010-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Bulgaria', 'Germany', 'Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Vice President of Medical Affairs', 'organization': 'Transcend Medical, Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative).', 'description': 'Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Non-Ocular Adverse Events', 'description': 'At risk population for non-ocular adverse events is included with unit of subjects', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Ocular Adverse Events', 'description': 'At risk population for ocular adverse events is included with unit of eyes.', 'otherNumAtRisk': 50, 'otherNumAffected': 36, 'seriousNumAtRisk': 50, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Hyphema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BCVA loss ≥ 2 lines at/after 3 months postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary surgical intervention: IOP management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IOP ≥ 10 mmHg over baseline or > 30 mmHg at/after 1 month postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CyPass device obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary surgical intervention: Cataract removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary surgical intervention: CyPass obstruction lysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Secondary surgical intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IOP above target', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyPass Micro-Stent', 'description': 'Subjects received the CyPass Micro-Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Month 12 postoperative', 'description': 'IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Eyes implanted with the CyPass 2FX device with data available.'}, {'type': 'SECONDARY', 'title': 'Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyPass Micro-Stent', 'description': 'Subjects received the CyPass Micro-Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12 postoperative', 'description': 'Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Eyes implanted with the CyPass 2FX device with data available.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyPass Micro-Stent', 'description': 'Subjects received the CyPass Micro-Stent'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 postoperative', 'description': 'The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.', 'unitOfMeasure': 'medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Eyes implanted with the CyPass 2FX device with data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CyPass Micro-Stent', 'description': 'Subjects received the CyPass Micro-Stent'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study Closed at Site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 7 investigational sites in Germany, Bulgaria, Spain and Austria.', 'preAssignmentDetails': 'This reporting group includes all treated participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CyPass Micro-Stent', 'description': 'Subjects received the CyPass Micro-Stent'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '10.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2010-07-14', 'resultsFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2010-07-19', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-08', 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline', 'timeFrame': 'Baseline; Month 12 postoperative', 'description': 'IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication', 'timeFrame': 'Month 12 postoperative', 'description': 'Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.'}, {'measure': 'Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline', 'timeFrame': 'Baseline, Month 12 postoperative', 'description': 'The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Glaucoma device', 'Glaucoma surgery', 'Intraocular pressure'], 'conditions': ['Primary Open Angle Glaucoma (POAG)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of POAG\n* Medicated IOP ≥ 21 and ≤ 35 mmHg\n* Use of 1 - 4 topical IOP lowering medications\n\nExclusion Criteria:\n\n* Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma\n* Use of oral hypotensive medication treatment for glaucoma\n* Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure\n* Clinically significant ocular pathology other than POAG'}, 'identificationModule': {'nctId': 'NCT01166659', 'acronym': 'DUETTE', 'briefTitle': 'Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'TMI-10-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CyPass Micro-Stent', 'description': 'Subjects receive the CyPass Micro-Stent', 'interventionNames': ['Device: CyPass Micro-Stent']}], 'interventions': [{'name': 'CyPass Micro-Stent', 'type': 'DEVICE', 'description': 'The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.', 'armGroupLabels': ['CyPass Micro-Stent']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Vice President of Medical Affairs', 'role': 'STUDY_CHAIR', 'affiliation': 'Transcend Medical, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transcend Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}