Clinical efficacy was evaluated in 2 randomized, double-masked, placebo-controlled trials in which subjects with an anterior chamber cell grade ≥ “2” (a cell count of 11 or higher) after cataract surgery were assigned to DUREZOL or placebo (vehicle) following surgery. One drop of DUREZOL or vehicle was self instilled either 2 times per day or 4 times per day for 14 days, beginning the day after surgery. The presence of complete clearing (a cell count of 0) was assessed 8 and 15 days post-surgery using a slit lamp binocular microscope. In the intent-to-treat analyses of both studies, a significant benefit was seen in the 4 times per day DUREZOL –treated group in ocular inflammation and reduction of pain when compared with placebo. The consolidated clinical trial results are provided below.
Dr. Melton: To me, the term “mucoadhesive” translates into a drop that might blur vision. Yet, if you look at the two Phase III studies, zero patients out of 203 in the first study and zero patients out of 206 in the second study had drug-related blurred vision, and that's on the active drug, which is pretty remarkable. 3–5 This has clinically been supported by my own experience putting patients on LE gel and not getting any negative feedback regarding blurred vision. It's a pretty viscous, mucoadhesive drop, and because of its adaptive viscosity characteristics, it is unique as a gel.