Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04761705
Status:
SUSPENDED
Last Update Posted:
2024-05-10
First Post:
2021-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077338', 'term': 'Latanoprost'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'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'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'whyStopped': 'Awaiting transition to Part 2', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP)', 'timeFrame': 'From Baseline to Day 28 of Treatment', 'description': 'Change from baseline in Intraocular Pressure (IOP)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['open angle glaucoma', 'Ocular Hypertension'], 'conditions': ['Ocular Hypertension', 'Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The aim of this research study is to assess the safety and feasibility of lowering intraocular pressure (IOP) using an experimental study drug, JV-GL1.', 'detailedDescription': 'This is an open-label, dose escalation and dose expansion, study in adult participants with open-angle glaucoma or ocular hypertension. The study is divided into 2 parts:\n\nPart 1 of the study is a dose escalation, sequentially testing escalating doses of JV-GL1.\n\nPart 2 of the study will be randomized 2:2:1 (Experimental Dose A: Experimental Dose B: Active Control), treating additional subjects at the selected JV-GL1 doses or Latanoprost for 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral open-angle glaucoma or ocular hypertension\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04761705', 'briefTitle': 'Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'JeniVision, Inc.'}, 'officialTitle': 'A Phase 1/2 Safety and Efficacy Study of JV-GL1 Applied to the Periorbital Skin in Subjects With Open-Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'JV-GL1-OCU-GL-101/201-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized Part 2, Arm 1', 'description': 'Dose 1 selected in Part I', 'interventionNames': ['Drug: JV-GL1']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Part 2, Arm 2', 'description': 'Dose 2 selected in Part I', 'interventionNames': ['Drug: JV-GL1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized Part 2, Arm 3', 'interventionNames': ['Drug: Latanoprost 0.005% Ophthalmic Solution']}], 'interventions': [{'name': 'JV-GL1', 'type': 'DRUG', 'description': 'Experimental Treatment', 'armGroupLabels': ['Randomized Part 2, Arm 1', 'Randomized Part 2, Arm 2']}, {'name': 'Latanoprost 0.005% Ophthalmic Solution', 'type': 'DRUG', 'description': 'Active Control', 'armGroupLabels': ['Randomized Part 2, Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'overallOfficials': [{'name': 'David Wirta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Research Foundation, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JeniVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}