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Richard L Lindstrom,1 James C Loden,2 Thomas R Walters,3 Steven H Dunn,4 J Steven Whitaker,5 Terry Kim,6 Gregory A Demopulos,5 Khiun Tjia7 1Minnesota Eye Consultants, Minneapolis, MN, USA; 2Loden Vision Centers, Goodlettsville, TN, USA; 3Texan Eye Care, Austin, TX, USA; 4Houston Eye Associates, Houston, TX, USA; 5Omeros Corporation, Seattle, WA, USA; 6Duke University Eye Center, Durham, NC, USA; 7Isala Clinics, Zwolle, the Netherlands Background: The purpose of this study was to evaluate the effect of OMS302 on intraoperative pupil diameter and early postoperative ocular pain when administered during intraocular lens replacement surgery.Methods: Four hundred and six patients (406study eyes; 202in the OMS302group and 204in the placebo group) were entered into this randomized, double-masked, placebo-controlled, multicenter Phase III study, which was conducted at 15centers in the USA and the Netherlands. The patients received OMS302(60.75mM phenylephrine HCl and 11.25mM ketorolac tromethamine) or placebo in irrigation solution during intraocular lens replacement. No other changes in procedure were required. Coprimary endpoints were change in pupil diameter over time from surgical baseline to end of procedure and patient-reported ocular pain during the first 12hours postoperatively. Secondary endpoints included additional measures of pupil diameter and postoperative pain. Results: OMS302was superior to placebo in maintaining intraoperative mydriasis, preventing miosis, and reducing postoperative pain. The weighted mean (standard error) difference (OMS302– placebo) in change in the area under the curve from baseline for pupil diameter was 0.590([0.049]; 95% confidence interval 0.494 to 0.686; P |