title: A randomized, multicenter phase 3 study comparing 2% rebamipide (OPC-12759) with 0.1% sodium hyaluronate in the treatment of dry eye.
abstract: OBJECTIVE
  To investigate the efficacy of 2% rebamipide ophthalmic suspension compared with 0.1% sodium hyaluronate ophthalmic solution for the treatment of patients with dry eye.
  
  
  METHODS
  Randomized, multicenter, active-controlled parallel-group study.
  
  
  METHODS
  One hundred eighty-eight patients with dry eye.
  
  
  METHODS
  Following a 2-week screening period, patients were allocated randomly to receive 2% rebamipide or 0.1% sodium hyaluronate, administered as 1 drop in each eye 4 or 6 times daily, respectively, for 4 weeks.
  
  
  METHODS
  There were 2 primary end points: changes in the fluorescein corneal staining (FCS) score to determine noninferiority of 2% rebamipide and changes in the lissamine green conjunctival staining (LGCS) score to determine superiority. Secondary objective end points were Schirmer's test results and tear film breakup time (TBUT). Secondary subjective end points were dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision) score and the patients' overall treatment impression score.
  
  
  RESULTS
  In the primary analysis, the mean change from baseline in FCS scores verified noninferiority, indicated significant improvement, and, in LGCS scores, verified the superiority of 2% rebamipide to 0.1% sodium hyaluronate. Values for the Schirmer's test and TBUT were comparable between the 2 groups. For 2 dry eye-related ocular symptoms--foreign body sensation and eye pain--2% rebamipide showed significant improvements over 0.1% sodium hyaluronate. Patients had a significantly more favorable impression of 2% rebamipide than of 0.1% sodium hyaluronate; 64.5% rated treatment as improved or markedly improved versus 34.7%, respectively. No serious adverse events were observed.
  
  
  CONCLUSIONS
  Administration of 2% rebamipide was effective in improving both the objective signs and subjective symptoms of dry eye. Those findings, in addition to the well-tolerated profile of 2% rebamipide, clearly show that it is an effective therapeutic method for dry eye.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors.affiliation: Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan. shigeruk@koto.kpu-m.ac.jp
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kinoshita
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Oshiden
authors.forename: Saki
authors.initials: S
authors.lastname: Awamura
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Suzuki
authors.forename: Norihiro
authors.initials: N
authors.lastname: Nakamichi
authors.forename: Norihiko
authors.initials: N
authors.lastname: Yokoi
mesh_terms: D000328:Adult; D000368:Aged; D000409:Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004396:Coloring Agents / Q000378:metabolism; D003228:Conjunctiva / Q000378:metabolism; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D015590:Fluorophotometry; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008086:Lissamine Green Dyes / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000627:therapeutic use; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013666:Tears / Q000502:physiology; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D000897:Anti-Ulcer Agents; D004396:Coloring Agents; D008086:Lissamine Green Dyes; D009883:Ophthalmic Solutions; D015363:Quinolones; D055675:Viscosupplements; D006820:Hyaluronic Acid; C052785:rebamipide; D000409:Alanine