Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: A randomized, vehicle-controlled clinical trial

(PURPOSE)-P-.: To investigate the efficacy and safety of ketorolac trometha mine 0.5% ophthalmic solution (Acular; Allergan, Inc, Irvine, California) i n the treatment of moderate to severe anterior segment inflammation develop ing after unilateral cataract surgery with intraocular lens implantation. (METHODS)-M-.: Only patients who exhibited moderate or greater levels of ce lls and flare 1 day after surgery were included in this multicenter, double -masked, randomly assigned, parallel-group study, Topical ketorolac or vehi cle solution (Allergan, Inc) was administered to the treated eye four times daily, starting the day after surgery and continuing for 14 days. (RESULTS)-R-.: Ketorolac was significantly more effective than the vehicle solution in reducing anterior chamber cells (P less than or equal to.030) a nd flare (P less than or equal to.025), conjunctival erythema (P less than or equal to.046), ciliary flush (P less than or equal to.006), tearing (P l ess than or equal to.012), photophobia (P less than or equal to.014), and p ain (P less than or equal to.049). Half as many patients from the ketorolac group (14/51) were discontinued from the study for lack of efficacy, compa red with the vehicle group (28/51; P=.005). There was no significant differ ence between ketorolac and the vehicle solution in changes in visual acuity , intraocular pressure, biomicroscopic or ophthalmoscopic variables, or adv erse events. (CONCLUSIONS)-C-.: Ketorolac tromethamine 0.5% ophthalmic solution is safe and provides substantial anti-inflammatory activity in the treatment of mod erate to severe anterior segment inflammation developing after cataract sur gery and intraocular lens implantation, (C) 1999 by Elsevier Science Inc. A ll rights reserved.