Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery.

Abstract

PURPOSE:

To evaluate the efficacy and safety of twice-daily, preservative-free ketorolac 0.45% (Acuvail; Allergan, Inc, Irvine, California, USA) administration for treatment of inflammation and pain after cataract surgery.

DESIGN:

Prospective, randomized trial.

METHODS:

Two multicenter, double-masked studies randomized 511 cataract surgery patients (2:1) to receive twice-daily ketorolac 0.45% or vehicle in the operative eye for 16 days, beginning 1 day before surgery. The primary efficacy end point was the percentage of patients with a summed ocular inflammation score of 0 for anterior chamber cell and flare on postoperative day 14. The main secondary efficacy end point was the percentage of patients with no pain on postoperative day 1.

RESULTS:

On day 14, 52.5% of ketorolac patients and 26.5% of vehicle patients had an summed ocular inflammation score of 0 (P < .001). On day 1, 72.4% of ketorolac patients and 39.7% of vehicle patients had a pain score of 0 (P < .001). Median time to pain resolution was 1 day in the ketorolac group and 2 days in the vehicle group (P < .001). The percentage of ketorolac and vehicle patients who had a +3-line or more improvement in best-corrected visual acuity from baseline was 60.5% versus 44.0% on day 14 (P = .002). Overall, adverse events were more prevalent in the vehicle group than in the ketorolac group (48.5% vs 35.2%; P = .004). Burning or stinging (per a composite Medical Dictionary for Regulatory Activities) was reported by 1.5% of ketorolac patients and 0.6% of vehicle patients.

CONCLUSIONS:

Twice-daily ketorolac 0.45% was well tolerated and effectively treated inflammation and pain following cataract surgery.

• Authors: Eric D Donnenfeld, Louis D Nichamin, David R Hardten, Michael B Raizman, William Trattler, Rajesh K Rajpal, Louis M Alpern, Carlos Felix, Ronald R Bradford, Linda Villanueva, David A Hollander, Rhett M Schiffman
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 151 Issue 3 Pg. 420-6.e1 (Mar 2011) ISSN: 1879-1891 [Electronic] United States
• PMID: 21145532 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 Elsevier Inc. All rights reserved.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Preservatives, Pharmaceutical
• Ketorolac

Topics

• Adult
• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Double-Blind Method
• Eye Pain (drug therapy, etiology)
• Female
• Humans
• Ketorolac (administration & dosage, adverse effects)
• Lens Implantation, Intraocular
• Male
• Middle Aged
• Pain Measurement
• Phacoemulsification
• Preservatives, Pharmaceutical (administration & dosage)
• Prospective Studies
• Treatment Outcome
• Uveitis, Anterior (drug therapy, etiology)
• Visual Acuity (physiology)