InflammationPhase 2NCT06164743
Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery
A Phase 2 study testing VVN461 Ophthalmic Solution 1.0% and VVN461 Ophthalmic Solution 0.5% in people with Inflammation, run by VivaVision Biotech, Inc at 10 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Inflammation
- What is being tested?
- VVN461 Ophthalmic Solution 1.0% and VVN461 Ophthalmic Solution 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 Jan 2024to 15 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- Any ocular pain at Visit 1 (Screening)
- Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Keystone Research
Austin, Texas, 78731
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
ICON Eye Care
Grand Junction, Colorado, 81501
Houston Eye Associates
Houston, Texas, 77708
United Medical Research Institute
Inglewood, California, 90301
Levenson Eye Associates
Jacksonville, Florida, 32204
Center For Sight - Las Vegas
Las Vegas, Nevada, 89145
North Bay Eye Associates
Petaluma, California, 94954
Martel Eye Associates
Rancho Cordova, California, 95670
Comprehensive Eye Care, Ltd
Washington, Missouri, 63090
About this study
Official title: A Phase 2, Double-masked, Randomized, Vehicle-controlled Study of VVN461 Ophthalmic Solution in Treating Post -Operative Ocular Inflammation in Subjects Undergoing Routine Unilateral Cataract Surgery
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
Read the detailed description
This is a phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the US assessing the safety and ocular efficacy of VVN461 for treating post-operative ocular inflammation in subjects who undergo routine unilateral CELR surgery via phacoemulsification without surgical complication. Approximately 90 subjects (30 per group) will be randomized in a 1:1:1 ratio. Subjects will administer 1 eye drop in the study eye four times a day (QID) for 14 days.
- Conditions
- Inflammation
- Being tested
- VVN461 Ophthalmic Solution 1.0%, VVN461 Ophthalmic Solution 0.5%, Vehicle
- Medical subject headings
- Inflammation
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
Topical ocular drug
VVN461 Ophthalmic Solution 0.5%Drug
Topical ocular drug
VehicleDrug
Topical ocular drug
| 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% |
| Vehicle | Placebo comparator | VVN461 Vehicle Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Cell (ACC): Categorical Cure
Proportion of subjects with grade of 0 using SUN Working Group Grading Scale (0 (none) to 4+ (>50 cells in field). Note - higher values represent a WORSE outcome.
Measured: Day 14
Secondary outcomes (1)
Safety of VVN461
Number of subjects with Adverse Events
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start11 Jan 2024
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InflammationStudies 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
- Model description
- Double-masked, parallel, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 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
- NCT06164743
- Sponsor's protocol ID
- VVN461-CS-201
- Status last verified
- Jun 2025
- First submitted
- 1 Dec 2023
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-masked, Randomized, Vehicle-controlled Study of VVN461 Ophthalmic Solution in Treating Post -Operative Ocular Inflammation in Subjects Undergoing Routine Unilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT06164743
- Acronym / sponsor ID
- VVN461-CS-201
- Conditions
- Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- VivaVision Biotech, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Posted 10 Jun 2025
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, 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
Detailed description
This is a phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the US assessing the safety and ocular efficacy of VVN461 for treating post-operative ocular inflammation in subjects who undergo routine unilateral CELR surgery via phacoemulsification without surgical complication. Approximately 90 subjects (30 per group) will be randomized in a 1:1:1 ratio. Subjects will administer 1 eye drop in the study eye four times a day (QID) for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-masked, parallel, randomized
| 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% |
| Vehicle | Placebo comparator | Drug: VehicleVVN461 Vehicle |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (2 listed)
- Any ocular pain at Visit 1 (Screening)
- Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs
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%Topical ocular drug | Drug | VVN461 1.0% |
| VVN461 Ophthalmic Solution 0.5%Topical ocular drug | Drug | VVN461 0.5% |
| VehicleTopical ocular drug | Drug | Vehicle |
Primary outcome
Anterior Chamber Cell (ACC): Categorical Cure
Time frame: Day 14
Proportion of subjects with grade of 0 using SUN Working Group Grading Scale (0 (none) to 4+ (>50 cells in field). Note - higher values represent a WORSE outcome.
1 secondary outcome
Safety of VVN461
Time frame: Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
10 sites 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% and VVN461 Ophthalmic Solution 0.5% in people with Inflammation, run by VivaVision Biotech, Inc at 10 sites in United States.
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 5 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: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anterior Chamber Cell (ACC): Categorical Cure (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 11 Sep 2026.