title: Efficacy of bromfenac sodium ophthalmic solution for treatment of dry eye disease.
abstract: OBJECTIVE
  To evaluate the efficacy of bromfenac sodium ophthalmic solution (BF) in patients with dry eye disease (DED) inadequately controlled by monotherapy with artificial tears (ATs).
  
  
  METHODS
  An investigator-oriented trial with a single-arm, nonrandomized, open-label design.
  
  
  METHODS
  Twenty-six patients, who showed no symptomatic improvement of DED after 1 month of AT treatment, were enrolled. Bromfenac sodium ophthalmic solution was administered adjunctively with AT for 1 month. The BF treatment was then discontinued, and AT treatment alone was continued for 3 months. The signs and symptoms were evaluated at the beginning of BF treatment (Pre), at the end of the combined BF and AT treatment (BF1M), and at 1 and 3 months after discontinuation of BF treatment (Po1M and Po3M, respectively).
  
  
  RESULTS
  The dryness scores at BF1M were significantly improved compared with Pre (P < 0.001) and significantly superior to Po3M (P < 0.001). No significant changes in the Schirmer scores were observed throughout the treatment period. The tear film breakup time was significantly improved at BF1M (4.4 ± 2.3 seconds) compared with Pre (2.8 ± 1.8 seconds; P < 0.001). Superficial punctate keratopathy showed significant improvements in the total score of area and density at BF1M compared with Pre (P < 0.001). However, these parameters had significantly worsened at Po3M compared with BF1M. No adverse events were observed.
  
  
  CONCLUSIONS
  Bromfenac sodium ophthalmic solution has improved the dryness of the eye and signs of DED through its anti-inflammatory effects. Nonsteroidal anti-inflammatory drugs were suitable as anti-inflammatory ophthalmic solutions for patients with DED.
authors.affiliation: From the *Department of Ophthalmology, Tsurumi University School of Dental Medicine, Kanagawa; and †Department of Ophthalmology, Tokyo Saiseikai Central Hospital; and ‡J&J Ocular Surface and Visual Optics Department, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Fujishima
authors.forename: Miki
authors.initials: M
authors.lastname: Fuseya
authors.forename: Masarou
authors.initials: M
authors.lastname: Ogata
authors.forename: Dogru
authors.initials: D
authors.lastname: Murat
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001577:Benzophenones / Q000627:therapeutic use*; D001969:Bromobenzenes / Q000627:therapeutic use*; D003315:Cornea / Q000187:drug effects; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001577:Benzophenones; D001969:Bromobenzenes; D009883:Ophthalmic Solutions; C053083:bromfenac