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: 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: 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: Ketorolac was significantly more effective than the vehicle solution in reducing anterior chamber cells (P < or = .030) and flare (P < or = .025), conjunctival erythema (P < or = .046), ciliary flush (P < or = .006), tearing (P < or = .012), photophobia (P < or = .014), and pain (P < or = .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: 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.