title: Efficacy and safety of indomethacin 0.1% eye drops compared with ketorolac 0.5% eye drops in the management of ocular inflammation after cataract surgery.
abstract: OBJECTIVE
  To determine whether indomethacin 0.1% eye drops are at least as effective as ketorolac 0.5% eye drops in treating ocular inflammation following cataract surgery.
  
  
  METHODS
  Prospective, multicenter, investigator-masked, parallel-group, randomized, active-controlled clinical trial. Cataract patients were randomized in a 1:1 ratio to receive indomethacin or ketorolac administered QID for 3 weeks beginning 1 day before surgery. The primary end-point was aqueous flare measured by laser flare meter at postoperative Days 1 and 7. Secondary end-points included retinal thickness, slit lamp and funduscopic examinations and postsurgical pain ratings. Safety and tolerability were also assessed.
  
  
  RESULTS
  A total of 86 patients were included in the per protocol population (n = 43 per treatment group). Indomethacin was found non-inferior to ketorolac for comparison of aqueous flare at postoperative Days 1 and 7 (Day 1: 95% CI: -2.37, 5.50; non-inferiority upper margin, 15 ph/ms and Day 7: 95% CI: -7.83, -0.94; non-inferiority upper margin, 8 ph/ms) and statistically better than ketorolac at Day 7 (p = 0.013). There were no significant between-group differences in aqueous flare and change from baseline in retinal thickness at postoperative Days 30 and 90. Indomethacin showed a higher subjective tolerance rating than ketorolac at postoperative Days 7 and 30 (p ≤ 0.044).
  
  
  CONCLUSIONS
  Indomethacin 0.1% was at least as effective as ketorolac 0.5% at Day 1 and more effective than ketorolac 0.5% at Day 7 in treating ocular inflammation after uncomplicated cataract surgery. Indomethacin was better tolerated than ketorolac. There were no clinically meaningful safety concerns with either treatment.
authors.affiliation: Department of Ophthalmology, Hotel Dieu University Hospital, Nantes, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Weber
authors.forename: Laurent
authors.initials: L
authors.lastname: Kodjikian
authors.forename: Friedrich E
authors.initials: FE
authors.lastname: Kruse
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Zagorski
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Allaire
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D009877:Endophthalmitis / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000009:adverse effects / Q000627:therapeutic use*; D007249:Inflammation / Q000188:drug therapy / Q000209:etiology; D020911:Ketorolac Tromethamine / Q000009:adverse effects / Q000627:therapeutic use*; D019654:Lens Implantation, Intraocular; D008297:Male; D009883:Ophthalmic Solutions; D018918:Phacoemulsification; D011183:Postoperative Complications; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D020911:Ketorolac Tromethamine; D007213:Indomethacin