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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
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.
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.
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.
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