Phase 2
N=91
Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery
Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT06164743 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Anterior Chamber Cell: Categorical Cure — 18; 16; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VVN461 Ophthalmic Solution 1.0% (Drug); VVN461 Ophthalmic Solution 0.5% (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VivaVision Biotech, Inc
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anterior Chamber Cell: Categorical Cure |
18; 16; 6 | — |
| SECONDARY Safety of VVN461 |
2; 3; 3 | — |
Summary
This is a multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the United States (US) in subjects undergoing routine unilateral cataract extraction and lens replacement (CELR) surgery via phacoemulsification
Eligibility Criteria
Inclusion Criteria
- ≥21 years of age and in good general health at Visit 1 (Screening)
- Willing and able to provide informed consent and provide relevant privacy authorization(s)
- Willing and able to comply with study requirements and visit schedule
- Clear ocular media (other than cataract) in the study eye
- Planning to undergo routine unilateral cataract surgery via phacoemulsification extraction and implantation of an intraocular lens.
Exclusion Criteria
- Any ocular pain at Visit 1 (Screening)
- Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs
Data sourced from ClinicalTrials.gov (NCT06164743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.