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This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVN461, 1.0% | Experimental | VVN461 Ophthalmic Solution, 1.0% |
|
| 1.0% prednisolone acetate | Active Comparator | 1.0% prednisolone acetate, Pred Forte |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14 | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with ACC grade of 0 in the study eye at Day 14 | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Lu | Contact | +8618816562189 | caroline.lu@vivavisionbio.com |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
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| 1.0% prednisolone acetate | 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 |
|