This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
407
Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.
Bausch & Lomb
Rochester, New York, United States
Resolution of Anterior Chamber Cells.
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Time frame: Visit 5 (Postoperative day 8)
Grade 0 Pain
Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain
Time frame: Visit 5 (Postoperative day 8)
Resolution of Anterior Chamber Cells
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Time frame: Visit 4-7 (postoperative day 3-18)
Grade 0 Pain
Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain
Time frame: Visits 4-7 (Postoperative days 3-18)
Resolution of Anterior Chamber Flare
Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.
Time frame: Visit 4-7 (postoperative day 3-18)
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