Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT03478293
Status:
TERMINATED
Last Update Posted:
2022-09-09
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Single (Outcomes Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-06', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP reduction at 12 and 24 months on same number or fewer medications', 'timeFrame': '12 months and 24 months', 'description': 'IOP reduction at 12 and 24 months on same number or fewer medications'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Primary Open Angle Glaucoma (POAG)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.', 'detailedDescription': 'The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with primary open angle glaucoma (POAG)\n* Subject on two ocular hypotensive medications\n\nExclusion Criteria:\n\n* Traumatic, uveitic, neovascular, or angle closure glaucoma\n* Fellow eye already enrolled'}, 'identificationModule': {'nctId': 'NCT03478293', 'briefTitle': 'iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications', 'orgStudyIdInfo': {'id': 'GCF-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iStent inject surgery', 'description': 'Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject', 'interventionNames': ['Device: iStent inject surgery']}], 'interventions': [{'name': 'iStent inject surgery', 'type': 'DEVICE', 'description': 'Micro-invasive glaucoma surgery (MIGS) to implant iStent inject', 'armGroupLabels': ['iStent inject surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023-62', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Department of Ophthalmology - UNIFESP/ Hospital São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Kerry Stephens, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glaukos Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}