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The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with intraocular postoperative inflammation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difluprednate Ophthalmic Emulsion | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in anterior chamber cell score at day 14 after start of instillation from the baseline level (differences from the baseline score) were compared between the 2 treatment groups. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in anterior chamber cell score at days 3 and 7 after start of instillation were compared between the 2 treatment groups. | ||
| The numbers of patients showing an anterior chamber cell score of "0" at days 3, 7 and 14 after start of instillation were compared between the 2 treatment groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeaki Ohno | Department of Ophthalmology and Visual Sciences, Graduate School of Medicine, Hokkaido University | Study Chair |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| The changes in anterior chamber flare score at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups. |
| The changes in the total scores of subjective symptoms and objective signs at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups. |