Dose-response study of piroxicam ophthalmic solution vs flurbiprofen 0.03% in sustaining mydriasis during cataract surgery

Purpose: To compare the safety and effectiveness of 0,3% and 0.1 % piroxicam ophthalmic solution to placebo and flurbiprofen ophthalmic solution 0.03% in controlling intraoperative miosis during cataract surgery. Methods; Randomized, double-masked, placebo-and positive-controlled, parallel group study of 78 adult patients requiring cataract phacoemulsification with implantation of a small incision IOL. After informed consent, patients who met study criteria received two drops each of either piroxicam 0.3%, 0.1%, placebo, or flurbiprofen 0.03% with the cycloplegic and mydriatic, in the operative eye, spaced at 3 to 5 minute intervals, immediately prior to surgery. Pupils were measured using a pupillometer during surgery at the following intervals:l) prior to the initial incision, 2) at capsulotomy completion, 3)after nucleus removal, and 4) after IOL insertion. Results: Piroxicam 0.3% was significantly more effective than placebo in maintaining pupillary mydriasis and also exhibited greater effectiveness than piroxicam 0.1% in maintaining mydriasis. No statistically significant difference was found between piroxicam 0.3% and flurbiprofen 0.03% for this indication. Furthermore, piroxicam 0.3% and piroxicam 0.1% were statistically significantly more comfortable to the patient than flurbiprofen 0.03% upon instillation. A total of 14 patients experienced adverse events, none of which were serious. Conclusions: Piroxicam 0.3% is significantly more effective than placebo, and is superior to 0.1% in sustaining intraoperative mydriasis. There is no significant difference between piroxicam 0.3% and flurbiprofen 0.03% in sustaining intraoperative mydriasis. Piroxicam 0.3% and 0.1% are both safe for human use,and are both statistically significantly more comfortable than flurbiprofen 0.03% when administered to the human eye.