The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.
A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
394
Hull Eye Center
Lancaster, California, United States
Number of Participants With Anterior Chamber Cell Clearing
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
Time frame: Day 8
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