The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.
The objective is to assess the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). In addition, the evaluation system for a future dose-finding phase III study of difluprednate ophthalmic emulsion will be established.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
The flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).
The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.
The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
with the baseline total score (S0).
As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
(cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline
total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was
compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.
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