Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-03 @ 1:56 AM
Study NCT ID:
NCT07136805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C009935', 'term': 'prednisolone acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects with ACC grade of 0 in the study eye at Day 14', 'timeFrame': 'Day 14'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-infectious Anterior Uveitis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At the time of signing the informed consent form (ICF), the subject must be aged 18 to 70 years (inclusive);\n* At screening, the affected eye is diagnosed with non-infectious anterior uveitis (acute or recurrent acute, only unilateral eye affected patients are included);\n* At screening, the ACC grade of the affected eye is 2+ or 3+ \\[SUN criteria\\];\n* At screening, the ACF grade of the affected eye is ≥1 \\[SUN criteria\\];\n\nExclusion Criteria:\n\n* At screening, the affected eye has an ACC grade of 4+ or hypopyon\n* Diagnosis of intermediate uveitis, posterior uveitis, or panuveitis in either eye at the time of screening'}, 'identificationModule': {'nctId': 'NCT07136805', 'briefTitle': 'A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'VivaVision Biotech, Inc'}, 'officialTitle': 'A Multi-center, Randomized, Single-masked, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of 1.0% VVN461 Ophthalmic Solution in Patients With Non-infectious Anterior Uveitis', 'orgStudyIdInfo': {'id': 'VVN461-CCS-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VVN461, 1.0%', 'description': 'VVN461 Ophthalmic Solution, 1.0%', 'interventionNames': ['Drug: VVN461 Ophthalmic Solution 1.0%']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1.0% prednisolone acetate', 'description': '1.0% prednisolone acetate, Pred Forte', 'interventionNames': ['Drug: 1.0% prednisolone acetate']}], 'interventions': [{'name': 'VVN461 Ophthalmic Solution 1.0%', 'type': 'DRUG', 'description': '1 drop for study eye each time, 6 times daily (Q2h) for 7 days; 4 times daily (QID) for 7 days; 2 times daily (BID) for 7 days; 1 time daily for 7 days', 'armGroupLabels': ['VVN461, 1.0%']}, {'name': '1.0% prednisolone acetate', 'type': 'DRUG', 'description': '1 drop for study eye each time, 6 times daily (Q2h) for 7 days; 4 times daily (QID) for 7 days; 2 times daily (BID) for 7 days; 1 time daily for 7 days', 'armGroupLabels': ['1.0% prednisolone acetate']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Caroline Lu', 'role': 'CONTACT', 'email': 'caroline.lu@vivavisionbio.com', 'phone': '+8618816562189'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VivaVision Biotech, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}