title: Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain.
abstract: OBJECTIVE
  To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.09% dosed once daily for the treatment of ocular inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation.
  
  
  METHODS
  Randomized, double-masked, vehicle-controlled or active-controlled, multicenter, clinical trials.
  
  
  METHODS
  A total of 872 subjects (872 study eyes: bromfenac in 584, placebo in 288).
  
  
  METHODS
  Four randomized, double-masked, vehicle or active-controlled, clinical trials were conducted at 134 ophthalmology clinics in the United States. Subjects aged ≥ 18 years were randomized to receive either bromfenac 0.09% or placebo dosed once daily beginning 1 day before cataract surgery (day -1), continuing on the day of surgery (day 0), and continuing for an additional postoperative 14 days. Subjects were evaluated for efficacy and safety on days 1, 3, 8, 15, and 22. The primary efficacy end point was cleared ocular inflammation, measured by the summed ocular inflammation score (SOIS; anterior chamber cells and flare) by day 15. The secondary efficacy end point was the number of subjects who were pain-free at day 1. The data from the 4 trials were pooled for analyses.
  
  
  METHODS
  The SOIS and ocular pain.
  
  
  RESULTS
  The proportion of subjects who had cleared ocular inflammation by day 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The mean SOIS in the bromfenac 0.09% group was significantly lower than in the placebo group at days 3, 8, 15, and 22 (P < 0.0001). The proportion of subjects who were pain-free at days 1, 3, 8, and 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The incidence of adverse events reported in the bromfenac 0.09% group was significantly lower than in the placebo group (P < 0.0001). On day 15, 84.0% of the bromfenac subjects had ≥ 1-line improvement in visual acuity compared with 66.1% of placebo subjects (P < 0.0001).
  
  
  CONCLUSIONS
  Bromfenac 0.09% dosed once daily was clinically safe and effective for reducing and treating ocular inflammation and pain associated with cataract surgery.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors.affiliation: Ophthalmic Consultants of Boston, Boston, Massachusetts, USA.
authors.forename: Bonnie A
authors.initials: BA
authors.lastname: Henderson
authors.forename: Johnny L
authors.initials: JL
authors.lastname: Gayton
authors.forename: Simon P
authors.initials: SP
authors.lastname: Chandler
authors.forename: James A
authors.initials: JA
authors.lastname: Gow
authors.forename: Sharon M
authors.initials: SM
authors.lastname: Klier
authors.forename: Timothy R
authors.initials: TR
authors.lastname: McNamara
mesh_terms: 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; D002387:Cataract Extraction; D004311:Double-Blind Method; D023381:Endpoint Determination; D058447:Eye Pain / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000503:physiopathology; D019654:Lens Implantation, Intraocular; D008297:Male; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D010149:Postoperative Pain / Q000188:drug therapy*; D011183:Postoperative Complications; D019591:Pseudophakia / Q000503:physiopathology; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001577:Benzophenones; D001969:Bromobenzenes; D009883:Ophthalmic Solutions; C053083:bromfenac