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 efficacy endpoints in comparison with 0.1% BM ophthalmic solution, prior to investigation of the efficacy and safety of 0.05% DFBA ophthalmic emulsion in the treatment of postoperative intraocular inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
The variation from baseline in anterior chamber cell score on Day 14 (difference from baseline
score) was compared between the test and control groups.
The variations from baseline in anterior chamber cell score on Days 3 and 7 were compared
between the test and control groups.
The numbers of patients with an anterior chamber cell score of 0 on Days 7 and 14 were
compared between the test and control groups.
The variations from baseline in anterior chamber flare score on Days 3, 7 and 14 were
The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were
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