Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial

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.

Comparing two mucin secretagogues for the treatment of dry eye disease: a prospective randomized crossover trial

“…Both drugs have been reported to be effective for various kinds of DED including Sjogren’s syndrome, non-Sjogren ADDE, DWDE, and IEDE 5 – 9 . Diquafosol has also been used for decades in Korea, while rebamipide was recently introduced 10 . Although both drugs are known to increase the mucin levels of the ocular surface, their mechanisms of action are different.…”

“…A newly developed rebamipide in Korea has been modified from its original Japanese composition. The Korean rebamipide ophthalmic solution is clear, not a suspension, and is known to reduce blurring after instillation 10 . Furthermore, the manufacturer claimed that the bitter taste was significantly reduced by the addition of mannitol and menthol.…”