Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT06057051
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 245}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary open-angle glaucoma\n* Phakic or pseudophakic\n* Age 35 years or older\n\nExclusion Criteria:\n\n* Traumatic, uveitic, neovascular, angle-closure glaucoma or\n* glaucoma associated with vascular disorders\n* Active corneal inflammation or edema\n* Retinal disorders not associated with glaucoma'}, 'identificationModule': {'nctId': 'NCT06057051', 'briefTitle': 'Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Prospective, Multicenter Study of the Glaukos® iStent Infinite Trabecular Micro-Bypass System Model iS3 in Subjects With Mild to Moderate Primary Open-angle Glaucoma', 'orgStudyIdInfo': {'id': 'GLK-401-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iStent Infinite', 'description': 'iStent Infinite Trabecular Micro-Bypass System', 'interventionNames': ['Device: iStent Infinite']}], 'interventions': [{'name': 'iStent Infinite', 'type': 'DEVICE', 'description': 'iStent Infinite Trabecular Micro-Bypass System', 'armGroupLabels': ['iStent Infinite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dari Parizadeh', 'role': 'CONTACT'}], 'facility': 'Glaukos Investigator Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Dari Parizadeh', 'role': 'CONTACT', 'email': 'dparizadeh@glaukos.com', 'phone': '949-481-0575'}, {'name': 'Kerry Stephens', 'role': 'CONTACT', 'email': 'kstephens@glaukos.com', 'phone': '949-481-8057'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}