Ophthalmic NSAID effectively reduces pain, inflammation after cataract surgery

Am J Ophthalmol. 2011;151(3):420-426.

A reformulated ophthalmic nonsteroidal anti-inflammatory drug effectively treated pain and inflammation after cataract surgery, a study found.

"[Interest] in using topical NSAIDs against postoperative inflammation and pain has increased in recent years, and NSAIDs now are an integral part of the perioperative management, usually used concomitantly with corticosteroids to optimize surgical outcomes and to help meet patient expectations," the study authors said.

Investigators set out to assess the safety and efficacy of Acuvail (ketorolac 0.45%, Allergan) administered twice daily.

The two prospective phase 3 clinical trials conducted at 48 centers included 511 cataract patients randomized 2:1 to receive ketorolac or vehicle in the operated eye from 1 day before surgery to 14 days after surgery. Of 511 patients, 340 received ketorolac and 171 received vehicle.

Study results showed that 52.5% of ketorolac patients and 26.5% of controls had a summed ocular inflammation score of 0 at 14 days after surgery. The difference was statistically significant (P < .001).

Also at 14 days, 60.5% of ketorolac patients and 44% of vehicle patients gained three or more lines of best corrected visual acuity from baseline. The difference was statistically significant (P = .002).

The median time to pain resolution was 1 day for the ketorolac patients and 2 days for the vehicle patients; the difference was statistically significant (P < .001).

Results also showed that 81.2% of ketorolac patients and 57.1% of vehicle controls completed the study without using other medications for pain or inflammation (P = .001).

"Further clinical studies are warranted to compare perioperative use of ketorolac 0.45% with other NSAIDs for optimization of surgical outcomes," the authors said.