Eyeworld

77 EW RESIDENTS Month 2015 and phenylephrine) postoperative pain and moxifloxacin 0.5%; other ocular and oral analgesics were avoided unless deemed medically necessary. Postoperative ocular pain was eval- uated for up to 12 hours using the Visual Analog Scale. A total of 222 patients were included in the study and had interpretable surgical videos. The patients receiving OMS302 and phenylephrine maintained stable mydriasis throughout the case, while those receiving ketorolac or the balanced salt solution experienced miosis with a statistically signifi- cant difference by minute 4 of the procedure. OMS302 demonstrated less intraoperative miosis (defined by a pupillary diameter of less than 6 mm at any point from incision to closure) than the vehicle alone, ke- torolac, or phenylephrine (p<0.0001, p=0.0004, p=0.0216, respectively). The mean Visual Analog Scale (VAS) for postoperative ocular pain (2-12 hours after surgery), was significant- ly lower among OMS302-treated patients compared with patients who received either vehicle or phenylephrine and similar to those receiving ketorolac. The percentage of patients who experienced at least one adverse event was similar across each of the treatment groups and the total num- bers were very low and unlikely to be related to study treatment. Four patients in the vehicle group expe- rienced eye inflammation, anterior chamber cell, or conjunctival hy- peremia, whereas only one patient had eye pain and inflammation in the ketorolac group. Four patients in the phenylephrine group had blurry vision, an anterior chamber reaction or photophobia. In the OMS302 group there were five patients with an adverse event including inflam- mation, nausea, or headache. No patients discontinued the study because of an adverse event. The authors conclude that OMS302 was safe and efficacious in reducing postoperative ocular discomfort and maintaining intra- operative pupil dilation above 6 mm. Preoperative topical mydriatics plus intracameral irrigation of a mydriatic and/or anti-miotic can be more effective at maintaining mydriasis than topical mydriatics alone. Though phenylephrine alone was able to improve the dilation and ketorolac contributed to decreased post-operative pain, the combi- nation demonstrate superiority to either agent alone. OMS302 thus provided an additive effect in pre- venting intraoperative miosis and pain. Discussion Donnenfeld et al. performed a ran- domized, double-masked, full-facto- rial, parallel Phase 2 trial evaluating how the efficacy of OMS302 on intraoperative pupillary dilation and postoperative pain control compares with vehicle, phenyleph- rine alone, and ketorolac alone. This is a well-designed study that addresses two critical aspects of cataract surgery—pupillary dilation and post-operative pain. This study strongly demonstrates that the combination of ketorolac and phen- ylephrine is superior to its indepen- dent components in reducing miosis during cataract surgery. An important characteristic and strength of OMS302 is how it is administered. It is a preservative-free solution that is administered con- tinuously as part of the irrigation fluid during routine cataract sur- gery. This is critical as there are no changes needed in standard oper- ating procedure. In the study, this administration method also enables the trial medication to be efficiently masked for the purposes of the trial. Although the medication is adminis- tered intraoperatively, patients were still required to use routine preoper- ative medications. Additionally, the study was not designed to compare the effect of OMS302 alone to that of OMS302 plus a preoperative NSAID, as NSAIDs can themselves decease mydriasis. Although a statistically signif- icant reduction was shown with OMS302 in reducing miosis during continued on page 78

• Blank Page
• Blank Page (1)
• Blank Page (2)