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 tromethamine 0.5% ophthalmic solution (Acular; Allergan, Inc, Irvine, California) in the treatment of moderate to severe anterior segment inflammation developing after unilateral cataract surgery with intraocular lens implantation. (METHODS)-M-.: Only patients who exhibited moderate or greater levels of cells and flare 1 day after surgery were included in this multicenter, double-masked, randomly assigned, parallel-group study, Topical ketorolac or vehicle 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) and 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 less than or equal to.012), photophobia (P less than or equal to.014), and pain (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, compared with the vehicle group (28/51; P=.005). There was no significant difference between ketorolac and the vehicle solution in changes in visual acuity, intraocular pressure, biomicroscopic or ophthalmoscopic variables, or adverse events. (CONCLUSIONS)-C-.: Ketorolac tromethamine 0.5% ophthalmic solution is safe and provides substantial anti-inflammatory activity in the treatment of moderate to severe anterior segment inflammation developing after cataract surgery and intraocular lens implantation, (C) 1999 by Elsevier Science Inc. All rights reserved.