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The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the management of inflammation following ocular surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Difluprednate |
|
| 2 | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difluprednate | Drug | Difluprednate |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups. | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Vogel, MD | Sirion Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlotte Eye, Ear, Nose & Throat | Charlotte | North Carolina | 28210 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C015808 | difluprednate |
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| Other |
Vehicle |
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