Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT04615403
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2020-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Exchange of Travoprost Intraocular Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}}}}, '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': 'D000069557', 'term': 'Travoprost'}], 'ancestors': [{'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': 'ldoan@glaukos.com', 'phone': '949-481-8076', 'title': 'Study Manager', 'organization': 'Glaukos'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of data from this study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This was a single arm, open label study in a small number of subjects to assess safety of administration of a second implant and removal of the previous implant.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Implantation and Exchange', 'description': 'Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.\n\nTravoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 16, 'seriousNumAtRisk': 33, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Corneal pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diabetic retinopathy', 'notes': '1 event in study eye, 1 event in fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Iridodialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Posterior capsule opacification', 'notes': '1 event in study eye, 1 event in fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Retinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Conjunctivitis viral', 'notes': 'non-study eye AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atonic seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cerebral arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Trigeminal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Visual field defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Death of unknown cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implantation and Exchange', 'description': 'Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.\n\nTravoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': "Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye", 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (all subjects who underwent the exchange procedure)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implantation and Exchange', 'description': 'Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.\n\nTravoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Implantation and Exchange', 'description': 'Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.\n\nTravoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration since initial implant administration', 'classes': [{'categories': [{'measurements': [{'value': '1540.8', 'spread': '123.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'time (days) since the administration of the previous travoprost intraocular implant', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'safety population (all participants who underwent the exchange procedure)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-24', 'size': 1236393, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-21T11:08', 'hasProtocol': True}, {'date': '2022-03-02', 'size': 1012708, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-20T18:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2020-10-29', 'resultsFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-07', 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Safety', 'timeFrame': '12 Months', 'description': "Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.', 'detailedDescription': 'This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able and willing to attend scheduled follow-up exams for the duration of the study\n* Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form\n* Best spectacle corrected visual acuity of 20/80 or better in each eye.\n* Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.\n\nExclusion Criteria:\n\n* Glaucoma status as follows:\n\n * Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders\n* Corneal status as follows:\n\n * Any active inflammation or edema\n* Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:\n* Implantation of Travoprost Intraocular Implant\n* Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)\n* Fellow eye status as follows:\n\n * Fellow eye actively enrolled in this trial or any other clinical trial\n* Subject status as follows:\n\n * Pregnant or planning to become pregnant during the course of the study"}, 'identificationModule': {'nctId': 'NCT04615403', 'briefTitle': 'Study of Exchange of Travoprost Intraocular Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant', 'orgStudyIdInfo': {'id': 'IDOS-106-EXCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implantation and Exchange', 'description': 'Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.', 'interventionNames': ['Drug: Travoprost']}], 'interventions': [{'name': 'Travoprost', 'type': 'DRUG', 'description': 'Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision', 'armGroupLabels': ['Implantation and Exchange']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92545', 'city': 'Hemet', 'state': 'California', 'country': 'United States', 'facility': 'Inland Eye Specialists', 'geoPoint': {'lat': 33.74761, 'lon': -116.97307}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'North Bath Eye Associates, Inc.', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '80525', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eye Center of northern Colorado, PC', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '34209', 'city': 'Manatee', 'state': 'Florida', 'country': 'United States', 'facility': 'The Eye Associates of Manatee', 'geoPoint': {'lat': 27.49643, 'lon': -82.53954}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Eye', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Sight', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Jones Eye Clinic', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '01523', 'city': 'Lancaster', 'state': 'Massachusetts', 'country': 'United States', 'facility': "D'Ambrosio Eye Care", 'geoPoint': {'lat': 42.45565, 'lon': -71.67312}}, {'zip': '07079', 'city': 'South Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Northern New Jersey Eye Institute', 'geoPoint': {'lat': 40.74899, 'lon': -74.26126}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Eye Surgeons', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '78746', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texan Eye', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75965', 'city': 'Nacogdoches', 'state': 'Texas', 'country': 'United States', 'facility': 'Lehmann Eye Center', 'geoPoint': {'lat': 31.60351, 'lon': -94.65549}}, {'city': 'Makati City', 'country': 'Philippines', 'facility': 'Asian Eye Institute', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}