title: Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.affiliation: Ophthalmic Consultants of Long Island, Rockville Centre, New York 11570, USA. eddoph@aol.com
authors.forename: Eric D
authors.initials: ED
authors.lastname: Donnenfeld
authors.forename: Louis D
authors.initials: LD
authors.lastname: Nichamin
authors.forename: David R
authors.initials: DR
authors.lastname: Hardten
authors.forename: Michael B
authors.initials: MB
authors.lastname: Raizman
authors.forename: William
authors.initials: W
authors.lastname: Trattler
authors.forename: Rajesh K
authors.initials: RK
authors.lastname: Rajpal
authors.forename: Louis M
authors.initials: LM
authors.lastname: Alpern
authors.forename: Carlos
authors.initials: C
authors.lastname: Felix
authors.forename: Ronald R
authors.initials: RR
authors.lastname: Bradford
authors.forename: Linda
authors.initials: L
authors.lastname: Villanueva
authors.forename: David A
authors.initials: DA
authors.lastname: Hollander
authors.forename: Rhett M
authors.initials: RM
authors.lastname: Schiffman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D058447:Eye Pain / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D020910:Ketorolac / Q000008:administration & dosage* / Q000009:adverse effects; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D018918:Phacoemulsification; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage; D011446:Prospective Studies; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000209:etiology; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011310:Preservatives, Pharmaceutical; D020910:Ketorolac