1. Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial
- Author
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Youngsub Eom, So Hyang Chung, Tae-Young Chung, Jae Yong Kim, Chul Young Choi, Kyung Chul Yoon, Byung Yi Ko, Hong Kyun Kim, Mee Kum Kim, Hyung Keun Lee, Jong Suk Song, Joon Young Hyon, Kyoung Yul Seo, Jong Soo Lee, and Hyo Myung Kim
- Subjects
Dry Eye Disease ,Quinolones ,Cornea ,Tears ,Intraocular pressure ,Ophthalmology ,RE1-994 - Abstract
Abstract Background To evaluate the efficacy of 1% and 2% rebamipide clear solution in the treatment of dry eye disease (DED). Methods Two hundred twenty patients with DED were randomly assigned to one of three groups: the 1% rebamipide, 2% rebamipide, or placebo (eye drops containing the same ingredients, except for the active components). Each eye drop was instilled four times daily for 12 weeks. Changes in tear film break-up time (TBUT), corneal and conjunctival staining score, Schirmer 1 test, and the Ocular Surface Disease Index (OSDI) from baseline to 12-week visit between the study groups were compared for efficacy assessment. Results The mean age of study patients was 43.8±14.2 years. The 1% and 2% rebamipide groups showed greater improvement in TBUT (1.99±1.87 and 2.02±2.21 s) at 12 weeks from baseline than the placebo group (1.25±2.93 s). The 2% rebamipide group showed greater improvement in the corneal staining score (− 3.15±2.00) at 12 weeks from baseline than the placebo group (− 2.85±1.80). The 1% and 2% rebamipide groups showed improvement in Schirmer 1 test (1.27±3.86 and 1.50±4.14 mm) at 12 weeks of treatment, but not the placebo group (0.55±2.99 mm). Both the rebamipide groups and the placebo group showed significantly improved OSDI after treatment for 12 weeks; however, there was no significant difference among the three groups. Conclusions 1% and 2% rebamipide clear solutions are an effective therapeutic option for improving TBUT and tear volume, and stabilizing the corneal staining score in DED.
- Published
- 2023
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