A Randomized, Multicenter Phase 3 Study Comparing 2% Rebamipide (OPC-12759) with 0.1% Sodium Hyaluronate in the Treatment of Dry Eye – Corrected Proof
Objective:
To investigate the efficacy of 2% rebamipide ophthalmic suspension compared with 0.1% sodium hyaluronate ophthalmic solution for the treatment of patients with dry eye.
Design:
Randomized, multicenter, active-controlled parallel-group study.
Participants:
One hundred eighty-eight patients with dry eye.
Methods:
Following a 2-week screening period, patients were allocated randomly to receive 2% rebamipide or 0.1% sodium hyaluronate, administered as 1 drop in each eye 4 or 6 times daily, respectively, for 4 weeks.
Main Outcome Measures:
There were 2 primary end points: changes in the fluorescein corneal staining (FCS) score to determine noninferiority of 2% rebamipide and changes in the (Read more...)