title: A Randomized Multicenter Study Comparing 0.1%, 0.15%, and 0.3% Sodium Hyaluronate with 0.05% Cyclosporine in the Treatment of Dry Eye.
abstract: To investigate the efficacy of 0.1%, 0.15%, and 0.3% sodium hyaluronate (SH) artificial tears compared with 0.05% cyclosporine (CS) ophthalmic solution for the treatment of dry eye.
  
  
  
  One hundred seventy-six patients were recruited and randomized to receive of 0.1%, 0.15%, and 0.3% SH and 0.05% CS. There was a primary end point which is the changes in the fluorescein corneal staining (FCS) score to determine noninferiority of 0.1%, 0.15%, and 0.3% SH. Secondary objective end points were lissamine green conjunctival staining (LGCS) scores, Schirmer test, and tear film break-up time (TBUT). Secondary subjective end point was ocular surface disease index (OSDI) score. These were evaluated before treatment and 6 and 12 weeks after start of treatment.
  
  
  
  In the primary analysis, the mean change from baseline in FCS scores verified noninferiority of 0.1% and 0.15% SH to 0.05% CS and also indicated significant improvement of all groups (P < 0.05). Values for TBUT, LGCS scores, and OSDI scores showed significant improvements in all groups (P < 0.05), although no significant intergroup difference was shown. However, Schirmer test scores in the 0.15% SH group showed a significant tendency for better improvement at week 12 compared with the other groups (P < 0.05). No serious adverse events were observed.
  
  
  
  Administration of 0.1%, 0.15%, and 0.3% SH was effective in improving both the objective signs and subjective symptoms of dry eye. Those findings, in addition to the well-tolerated profile of 0.1%, 0.15%, and 0.3% SH, show that it is effective therapeutic method for dry eye.
authors.affiliation: 1 Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea , Seoul, Korea.
authors.forename: Yuli
authors.initials: Y
authors.lastname: Park
authors.affiliation: 2 Department of Ophthalmology, Korea University Guro Hospital, Korea University College of Medicine , Seoul, Korea.
authors.forename: Jong Suk
authors.initials: JS
authors.lastname: Song
authors.affiliation: 3 Department of Ophthalmology, School of Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University , Seoul, Korea.
authors.forename: Chul Young
authors.initials: CY
authors.lastname: Choi
authors.affiliation: 4 Department of Ophthalmology, Chonnam National University Medical School , Gwangju, Korea.
authors.forename: Kyung Chul
authors.initials: KC
authors.lastname: Yoon
authors.affiliation: 5 The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine , Seoul, Korea.
authors.forename: Hyung Keun
authors.initials: HK
authors.lastname: Lee
authors.affiliation: 1 Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea , Seoul, Korea.
authors.forename: Hyun Seung
authors.initials: HS
authors.lastname: Kim
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D009883:Ophthalmic Solutions; D016572:Cyclosporine; D006820:Hyaluronic Acid
keywords: 0.05% cyclosporine; 0.1% sodium hyaluronate; 0.15% sodium hyaluronate; 0.3% sodium hyaluronate; dry eye syndrome