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

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)66-72
Number of pages7
JournalJournal of Ocular Pharmacology and Therapeutics
Volume33
Issue number2
DOIs
Publication statusPublished - 2017 Mar 1

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Hyaluronic Acid
Cyclosporine
Multicenter Studies
Staining and Labeling
Eye Diseases
Fluorescein
Tears
Therapeutics
Ophthalmic Solutions
Signs and Symptoms

Keywords

  • 0.05% cyclosporine
  • 0.1% sodium hyaluronate
  • 0.15% sodium hyaluronate
  • 0.3% sodium hyaluronate
  • dry eye syndrome

ASJC Scopus subject areas

  • Ophthalmology
  • Pharmacology
  • Pharmacology (medical)

Cite this

A Randomized Multicenter Study Comparing 0.1%, 0.15%, and 0.3% Sodium Hyaluronate with 0.05% Cyclosporine in the Treatment of Dry Eye. / Park, Yuli; Song, Jong-Suk; Choi, Chul Young; Yoon, Kyung Chul; Lee, Hyung Keun; Kim, Hyun Seung.

In: Journal of Ocular Pharmacology and Therapeutics, Vol. 33, No. 2, 01.03.2017, p. 66-72.

Research output: Contribution to journalArticle

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abstract = "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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AU - Yoon, Kyung Chul

AU - Lee, Hyung Keun

AU - Kim, Hyun Seung

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