Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05127551
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-15
First Post:
2021-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Diurnal Intraocular Pressure', 'timeFrame': 'Month 24', 'description': 'Change in Mean Diurnal Intraocular Pressure from Baseline over time'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Glaucoma', 'MIGS'], 'conditions': ['Glaucoma', 'Glaucoma, Open-Angle']}, 'referencesModule': {'references': [{'pmid': '40128494', 'type': 'DERIVED', 'citation': 'Ahmed IIK, Berdahl JP, Yadgarov A, Reiss GR, Sarkisian SR Jr, Gagne S, Robles M, Voskanyan LA, Sadruddin O, Parizadeh D, Giamporcaro JE, Kothe AC, Katz LJ, Navratil T. Six-Month Outcomes from a Prospective, Randomized Study of iStent infinite Versus Hydrus in Open-Angle Glaucoma: The INTEGRITY Study. Ophthalmol Ther. 2025 May;14(5):1005-1024. doi: 10.1007/s40123-025-01126-x. Epub 2025 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glacoma (PEXG) or Secondary Pigmentary Glaucoma (PG)\n\nExclusion Criteria:\n\n* Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders'}, 'identificationModule': {'nctId': 'NCT05127551', 'briefTitle': 'Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Comparitive Multicenter Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite® vs Competitor in Adult Subjects With Primary Open-Angle Glaucoma (POAG)', 'orgStudyIdInfo': {'id': 'INFI-103-COMP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iStent Infinite', 'description': 'Subjects implanted with iStent Infinite system', 'interventionNames': ['Device: iStent Infinite']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Competitor Device', 'description': 'Subject implanted with competitor device', 'interventionNames': ['Device: Competitor Device']}], 'interventions': [{'name': 'iStent Infinite', 'type': 'DEVICE', 'description': 'Implantation of the iStent Infinite', 'armGroupLabels': ['iStent Infinite']}, {'name': 'Competitor Device', 'type': 'DEVICE', 'description': 'Implantation of competitor device', 'armGroupLabels': ['Competitor Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1A 0A1', 'city': 'Montreal', 'state': 'Qubec', 'country': 'Canada', 'facility': 'Glaukos Investigator Sites', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}