Anterior UveitisPhase 2NCT06679153
A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
A Phase 2 study testing VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5% and Prednisolone acetate in people with Anterior Uveitis, run by VivaVision Biotech, Inc at 1 site in China.
Trial summary
This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anterior Uveitis
- What is being tested?
- VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5% and Prednisolone acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2023to 29 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age 18-70 years at the time providing signed informed consent
- At least 1 eye diagnosed with noninfectious anterior uveitis at the time of screening
- Willing and able to comply with study requirements and visit schedule
Who cannot join
- Diagnosis of intermediate uveitis, posterior uveitis or panuveitis in either eye at the time of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-masked, Active-controlled, Multi-center Phase 2 Clinical Study Evaluating the Efficacy and Safety of 0.5% and 1.0% VVN461 Ophthalmic Solution in Patients With Noninfectious Anterior Uveitis
This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis
Read the detailed description
In this study, subjects who meet the inclusion/exclusion criteria will be randomized to receive one of the three treatments prednisolone acetate during the Screening/Baseline Visit (Day-2 to Day 1). Starting from Visit 1 (Day 1), subjects will be administered one drop of the investigational product in the study eye in following dose regimens: 6 times per day (Q2h, 2 hours apart) for 7 days; 4 times per day (QID) for 7 days；2 times per day (BID) for 7 days；once a day (QD) for 7 days. Subjects will return to clinic for study assessments on Day 3 (Visit 2), Day 7 (Visit 3), Day 14 (Visit 4), Day 21 (Visit 5) and Day 28 (Visit 6, end of study) or early withdrawal/termination visit.
- Conditions
- Anterior Uveitis
- Being tested
- VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5%, Prednisolone acetate
- Medical subject headings
- Uveitis, Anterior
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
VVN461 Ophthalmic Solution, 1.0%, for up to 28 days
VVN461 Ophthalmic Solution 0.5%Drug
VVN461 Ophthalmic Solution, 0.5%, for up to 28 days
Prednisolone acetateDrug
Also called Pred Forte
Prednisolone acetate, 1%, for up to 28 days
| Study group | Role | What they receive |
|---|---|---|
| VVN461, 1.0% | Experimental | VVN461 Ophthalmic Solution, 1.0% Receives: Drug: VVN461 Ophthalmic Solution 1.0% |
| VVN461, 0.5% | Experimental | VVN461 Ophthalmic Solution, 0.5% Receives: Drug: VVN461 Ophthalmic Solution 0.5% |
| Prednisolone acetate, 1% | Placebo comparator | Prednisolone acetate Ophthalmic Solution, 1% Receives: Drug: Prednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACC score of ≥2 grade from baseline at Day 14
Proportion of subjects with improvement in ACC score of ≥2 grade from baseline at Day 14
Measured: Day 14
Secondary outcomes (1)
ACC score of 0
Proportion of subjects with an ACC score of 0 at any visit
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start27 Nov 2023
- Primary completion29 Dec 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 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
- NCT06679153
- Sponsor's protocol ID
- VVN461-CCS-201
- Status last verified
- Jan 2025
- First submitted
- 5 Nov 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Active-controlled, Multi-center Phase 2 Clinical Study Evaluating the Efficacy and Safety of 0.5% and 1.0% VVN461 Ophthalmic Solution in Patients With Noninfectious Anterior Uveitis
- ClinicalTrials.gov ID
- NCT06679153
- Acronym / sponsor ID
- VVN461-CCS-201
- Conditions
- Anterior Uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- VivaVision Biotech, IncIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 7 Nov 2024 (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, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis
Detailed description
In this study, subjects who meet the inclusion/exclusion criteria will be randomized to receive one of the three treatments prednisolone acetate during the Screening/Baseline Visit (Day-2 to Day 1). Starting from Visit 1 (Day 1), subjects will be administered one drop of the investigational product in the study eye in following dose regimens: 6 times per day (Q2h, 2 hours apart) for 7 days; 4 times per day (QID) for 7 days；2 times per day (BID) for 7 days；once a day (QD) for 7 days. Subjects will return to clinic for study assessments on Day 3 (Visit 2), Day 7 (Visit 3), Day 14 (Visit 4), Day 21 (Visit 5) and Day 28 (Visit 6, end of study) or early withdrawal/termination visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VVN461, 1.0% | Experimental | Drug: VVN461 Ophthalmic Solution 1.0%VVN461 Ophthalmic Solution, 1.0% |
| VVN461, 0.5% | Experimental | Drug: VVN461 Ophthalmic Solution 0.5%VVN461 Ophthalmic Solution, 0.5% |
| Prednisolone acetate, 1% | Placebo comparator | Drug: Prednisolone acetatePrednisolone acetate Ophthalmic Solution, 1% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years at the time providing signed informed consent
- At least 1 eye diagnosed with noninfectious anterior uveitis at the time of screening
- Willing and able to comply with study requirements and visit schedule
Key exclusion criteria (1 listed)
- 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%VVN461 Ophthalmic Solution, 1.0%, for up to 28 days | Drug | VVN461, 1.0% |
| VVN461 Ophthalmic Solution 0.5%VVN461 Ophthalmic Solution, 0.5%, for up to 28 days | Drug | VVN461, 0.5% |
| Prednisolone acetateAlso: Pred FortePrednisolone acetate, 1%, for up to 28 days | Drug | Prednisolone acetate, 1% |
Primary outcome
ACC score of ≥2 grade from baseline at Day 14
Time frame: Day 14
Proportion of subjects with improvement in ACC score of ≥2 grade from baseline at Day 14
1 secondary outcome
ACC score of 0
Time frame: Baseline to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5% and Prednisolone acetate in people with Anterior Uveitis, run by VivaVision Biotech, Inc at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ACC score of ≥2 grade from baseline 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 27 Jan 2025.