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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVN461 1.0% | Experimental | VVN461 Ophthalmic Solution, 1.0% |
|
| VVN461 0.5% | Experimental | VVN461 Ophthalmic Solution, 0.5% |
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| Vehicle | Placebo Comparator | VVN461 Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVN461 Ophthalmic Solution 1.0% | Drug | Topical ocular drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cell: 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. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of VVN461 | Number of subjects with Adverse Events | Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Medical Research Institute | Inglewood | California | 90301 | United States | ||
| North Bay Eye Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | VVN461 1.0% | VVN461 Ophthalmic Solution, 1.0% VVN461 Ophthalmic Solution 1.0%: Topical ocular drug |
| FG001 | VVN461 0.5% | VVN461 Ophthalmic Solution, 0.5% VVN461 Ophthalmic Solution 0.5%: Topical ocular drug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2024 | Jun 6, 2025 |
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Double-masked, parallel, randomized
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Double-masked drug product
| VVN461 Ophthalmic Solution 0.5% |
| Drug |
Topical ocular drug |
|
| Vehicle | Drug | Topical ocular drug |
|
| Petaluma |
| California |
| 94954 |
| United States |
| Martel Eye Associates | Rancho Cordova | California | 95670 | United States |
| ICON Eye Care | Grand Junction | Colorado | 81501 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| Comprehensive Eye Care, Ltd | Washington | Missouri | 63090 | United States |
| Center For Sight - Las Vegas | Las Vegas | Nevada | 89145 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Keystone Research | Austin | Texas | 78731 | United States |
| Houston Eye Associates | Houston | Texas | 77708 | United States |
| FG002 | Vehicle | VVN461 Vehicle Vehicle: Topical ocular drug |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | VVN461 1.0% | VVN461 Ophthalmic Solution, 1.0% VVN461 Ophthalmic Solution 1.0%: Topical ocular drug |
| BG001 | VVN461 0.5% | VVN461 Ophthalmic Solution, 0.5% VVN461 Ophthalmic Solution 0.5%: Topical ocular drug |
| BG002 | Vehicle | VVN461 Vehicle Vehicle: Topical ocular drug |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anterior Chamber Cell: 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. | Posted | Count of Participants | Participants | Day 14 |
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| Secondary | Safety of VVN461 | Number of subjects with Adverse Events | Posted | Count of Participants | Participants | Day 21 |
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21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VVN461 1.0% | VVN461 Ophthalmic Solution, 1.0% VVN461 Ophthalmic Solution 1.0%: Topical ocular drug | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | VVN461 0.5% | VVN461 Ophthalmic Solution, 0.5% VVN461 Ophthalmic Solution 0.5%: Topical ocular drug | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Vehicle | VVN461 Vehicle Vehicle: Topical ocular drug | 0 | 31 | 0 | 31 | 0 | 31 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanne Li | VivaVisionBio | (86) 021-58598290 | joanne.li@vivavisionbio.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2024 | Jun 9, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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