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A Randomized Multicenter Study Comparing 0.1%, 0.15%, and 0.3% Sodium Hyaluronate with 0.05% Cyclosporine in the Treatment of Dry Eye

 Yuli Park  ;  Jong Suk Song  ;  Chul Young Choi  ;  Kyung Chul Yoon  ;  Hyung Keun Lee  ;  Hyun Seung Kim 
 Journal of Ocular Pharmacology and Therapeutics, Vol.33(2) : 66-72, 2017 
Journal Title
 Journal of Ocular Pharmacology and Therapeutics 
Issue Date
Adult ; Cyclosporine/administration & dosage ; Cyclosporine/adverse effects ; Cyclosporine/therapeutic use* ; Dose-Response Relationship, Drug ; Dry Eye Syndromes/drug therapy* ; Female ; Humans ; Hyaluronic Acid/administration & dosage ; Hyaluronic Acid/adverse effects ; Hyaluronic Acid/therapeutic use* ; Male ; Middle Aged ; Ophthalmic Solutions/administration & dosage ; Ophthalmic Solutions/adverse effects ; Ophthalmic Solutions/therapeutic use*
0.05% cyclosporine ; 0.1% sodium hyaluronate ; 0.15% sodium hyaluronate ; 0.3% sodium hyaluronate ; dry eye syndrome
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Ophthalmology (안과학교실)
Yonsei Authors
이형근(Lee, Hyung Keun) ORCID logo https://orcid.org/0000-0002-1123-2136
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