Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-29 @ 8:26 PM
Study NCT ID:
NCT06230393
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-24
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IOP', 'timeFrame': '24months; 36 months; 48months, 60 months', 'description': 'From Screening to annual endpoints'}], 'secondaryOutcomes': [{'measure': 'Number of IOP lowering medications', 'timeFrame': '24months; 36 months; 48months, 60 months', 'description': 'Compared to screening in DF6-CL-20-01 trial'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intraocular Pressure', 'Glaucoma', 'MIGS'], 'conditions': ['Open Angle Glaucoma', 'Intraocular Pressure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM', 'detailedDescription': 'A Retrospective, nonrandomized, open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE® SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who participated in the DF6-CL-20-01 trial', 'eligibilityCriteria': 'Inclusion Criteria:\n\nparticipated in the DF6-CL-20-01 trial.\n\nExclusion Criteria:\n\nlost to follow up in the DF6-CL-20-01 trial'}, 'identificationModule': {'nctId': 'NCT06230393', 'briefTitle': 'An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.', 'organization': {'class': 'INDUSTRY', 'fullName': 'New World Medical, Inc.'}, 'officialTitle': 'An Extension Trial to Evaluate the Long Term Safety and Effectiveness of the STREAMLINE® SURGICAL SYSTEM in Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.', 'orgStudyIdInfo': {'id': 'DF6-CL-24-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'STREAMLINE® SURGICAL SYSTEM', 'type': 'DEVICE', 'description': 'STREAMLINE® SURGICAL SYSTEM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'San José', 'country': 'Costa Rica', 'facility': 'Clinica 20/20', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New World Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}