Non-infectious Anterior UveitisPhase 3NCT07136805
A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
A Phase 3 study testing VVN461 Ophthalmic Solution 1.0% and 1.0% prednisolone acetate in people with Non-infectious Anterior Uveitis, run by VivaVision Biotech, Inc at 2 sites in China.
Trial summary
This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-infectious Anterior Uveitis
- What is being tested?
- VVN461 Ophthalmic Solution 1.0% and 1.0% prednisolone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesChina
- Study dates
- 25 Nov 2025to 30 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of signing the informed consent form (ICF), the subject must be aged 18 to 70 years (inclusive);
- At screening, the affected eye is diagnosed with non-infectious anterior uveitis (acute or recurrent acute, only unilateral eye affected patients are included);
- At screening, the ACC grade of the affected eye is 2+ or 3+ [SUN criteria];
- At screening, the ACF grade of the affected eye is ≥1 [SUN criteria];
Who cannot join
- At screening, the affected eye has an ACC grade of 4+ or hypopyon
- Diagnosis of intermediate uveitis, posterior uveitis, or panuveitis in either eye at the time of screening
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University First Hospital
Beijing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
About this study
Official title: 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
This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China
- Conditions
- Non-infectious Anterior Uveitis
- Being tested
- VVN461 Ophthalmic Solution 1.0%, 1.0% prednisolone acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVN461 Ophthalmic Solution 1.0%Drug
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
1.0% prednisolone acetateDrug
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
| Study group | Role | What they receive |
|---|---|---|
| VVN461, 1.0% | Experimental | VVN461 Ophthalmic Solution, 1.0% Receives: Drug: VVN461 Ophthalmic Solution 1.0% |
| 1.0% prednisolone acetate | Active comparator | 1.0% prednisolone acetate, Pred Forte Receives: Drug: 1.0% prednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14
Measured: Day 14
Secondary outcomes (1)
The proportion of subjects with ACC grade of 0 in the study eye at Day 14
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start25 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious Anterior UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- VivaVision Biotech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136805
- Sponsor's protocol ID
- VVN461-CCS-301
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07136805
- Acronym / sponsor ID
- VVN461-CCS-301
- Conditions
- Non-infectious Anterior Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (actual)
- Lead sponsor
- VivaVision Biotech, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VVN461, 1.0% | Experimental | Drug: VVN461 Ophthalmic Solution 1.0%VVN461 Ophthalmic Solution, 1.0% |
| 1.0% prednisolone acetate | Active comparator | Drug: 1.0% prednisolone acetate1.0% prednisolone acetate, Pred Forte |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At the time of signing the informed consent form (ICF), the subject must be aged 18 to 70 years (inclusive);
- At screening, the affected eye is diagnosed with non-infectious anterior uveitis (acute or recurrent acute, only unilateral eye affected patients are included);
- At screening, the ACC grade of the affected eye is 2+ or 3+ [SUN criteria];
- At screening, the ACF grade of the affected eye is ≥1 [SUN criteria];
Key exclusion criteria (2 listed)
- At screening, the affected eye has an ACC grade of 4+ or hypopyon
- Diagnosis of intermediate uveitis, posterior uveitis, or panuveitis in either eye at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VVN461 Ophthalmic Solution 1.0%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 | Drug | VVN461, 1.0% |
| 1.0% prednisolone acetate1 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 | Drug | 1.0% prednisolone acetate |
Primary outcome
Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14
Time frame: Day 14
1 secondary outcome
The proportion of subjects with ACC grade of 0 in the study eye at Day 14
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VVN461 Ophthalmic Solution 1.0% and 1.0% prednisolone acetate in people with Non-infectious Anterior Uveitis, run by VivaVision Biotech, Inc at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14 (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.