title: Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery: results of 2 randomized controlled trials.
abstract: OBJECTIVE
  To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.07% (Prolensa) dosed once daily for the treatment of ocular inflammation and pain in subjects who underwent cataract surgery with posterior chamber intraocular lens implantation.
  
  
  METHODS
  Two phase 3, randomized, double-masked, placebo-controlled, multicenter clinical trials.
  
  
  METHODS
  Four hundred forty subjects (440 study eyes: 222 in the bromfenac group and 218 in the placebo group).
  
  
  METHODS
  Two phase 3, prospective, randomized, double-masked, placebo-controlled clinical trials were conducted at 39 ophthalmology clinics in the United States. Subjects 18 years of age or older were randomized to receive either bromfenac 0.07% or placebo dosed once daily beginning 1 day before cataract surgery, on the day of surgery, and continuing for 14 days after surgery (for a total of 16 days). Subjects were evaluated on days 1, 3, 8, 15, and 22 after surgery. The primary efficacy end point was cleared ocular inflammation, as measured by the summed ocular inflammation score of zero (anterior chamber cell count = 0 and absence of flare) by day 15. Secondary end points included cleared ocular inflammation at day 15 and the number of subjects who were pain free at day 1. The data from the 2 clinical trials were integrated for analyses.
  
  
  METHODS
  Summed ocular inflammation score and ocular pain.
  
  
  RESULTS
  A significantly higher proportion of subjects treated with bromfenac 0.07% achieved complete clearance of ocular inflammation by day 15 and at day 15 compared with placebo (P < 0.0001). A statistically significantly higher proportion of subjects in the bromfenac 0.07% group were pain free at all study visits compared with those in the placebo group (P < 0.0001). Fewer subjects in the bromfenac group (3.2%) discontinued investigational product early because of a lack of efficacy than in the placebo group (23.9%; P < 0.0001). The incidence of adverse events was significantly lower in the bromfenac 0.07% group compared with the placebo group (P = 0.0041).
  
  
  CONCLUSIONS
  Bromfenac ophthalmic solution 0.07% dosed once daily was clinically safe and effective compared with placebo for the treatment of ocular inflammation and pain in subjects who had undergone cataract surgery and may be a beneficial addition to the current standard of care, which commonly includes ophthalmic antibiotics and corticosteroids.
authors.affiliation: Texan Eye, Austin, Texas.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Walters
authors.affiliation: Wolstan Eye Associates, Torrance, California.
authors.forename: Damien F
authors.initials: DF
authors.lastname: Goldberg
authors.affiliation: United Medical Research Institute, Inglewood, California.
authors.forename: James H
authors.initials: JH
authors.lastname: Peace
authors.affiliation: Bausch and Lomb, Inc, Irvine, California.
authors.forename: James A
authors.initials: JA
authors.lastname: Gow
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001577:Benzophenones / Q000008:administration & dosage* / Q000009:adverse effects; D001969:Bromobenzenes / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D058447:Eye Pain / Q000188:drug therapy; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D019654:Lens Implantation, Intraocular; D008297:Male; D009883:Ophthalmic Solutions; D018918:Phacoemulsification; D011182:Postoperative Care / Q000379:methods; D011446:Prospective Studies; D016896:Treatment Outcome; D014605:Uveitis / Q000188:drug therapy
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001577:Benzophenones; D001969:Bromobenzenes; D009883:Ophthalmic Solutions; C053083:bromfenac