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This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis
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 daysï¼›2 times per day (BID) for 7 daysï¼›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.
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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% |
|
| Prednisolone acetate, 1% | Placebo Comparator | Prednisolone acetate Ophthalmic Solution, 1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVN461 Ophthalmic Solution 1.0% | Drug | VVN461 Ophthalmic Solution, 1.0%, for up to 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| ACC score of 0 | Proportion of subjects with an ACC score of 0 at any visit | Baseline to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D014606 | Uveitis, Anterior |
| ID | Term |
|---|---|
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
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| VVN461 Ophthalmic Solution 0.5% |
| Drug |
VVN461 Ophthalmic Solution, 0.5%, for up to 28 days |
|
| Prednisolone acetate | Drug | Prednisolone acetate, 1%, for up to 28 days |
|
|