Discussion
blurred vision, itching, ocular or visual symptoms, dry eye syndrome, Corneal Disease Study
DRY EYE, DRY EYE SYNDROME
This randomized controlled trial evaluated the efficacy and safety of 1% and 2% rebamipide clear solution in the treatment of Korean patients with DED. The results of this study showed that the 1% and 2% rebamipide clear solution resulted in greater TBUT improvement effect at 12 weeks of treatment compared to the placebo group. In addition, the 2% rebamipide clear solution showed significantly greater improvement in the corneal fluorescein staining scores at 12 weeks of treatment compared to the placebo group. The efficacy of rebamipide in improving TBUT and corneal fluorescein staining has been advocated previously in the literature [In this study, 12 weeks treatment of 1% and 2% rebamipide significantly improved tear volume represented as the Schirmer 1 test, but placebo did not. Unlike this study, previous randomized multicenter phase II and III studies evaluating the efficacy of 2% rebamipide solution haven’t show the improvement of Schirmer 1 test in dry eye patients [According to the Korean Corneal Disease Study Group (KCDSG) guidelines for the diagnosis and treatment of DED, patients presenting with at least ocular or visual symptoms as well as one of three objective signs, such as corneal fluorescein staining scores, TBUT, and Schirmer test, can be diagnosed with DED. This study intended to enroll dry eye patients with dry eye Levels I, II, or, III, as defined by the KCDSG guidelines. Thus, patients who presented with symptoms suggestive of dry eye syndrome for ≥ 6 months and with increased ocular surface staining and decreased Schirmer 1 test were enrolled. However, TBUT was not included in the inclusion criteria as most dry eye patients had short TBUT in South Korea and Japan in previous studies [The treatment recommended for patients with DED includes inoculation of artificial tears or anti-inflammatory agents (e.g., steroid or cyclosporine eye drops) [Diquafosol tetrasodium and rebamipide are well-known mucin secretagogues, and both are approved for the treatment of DED in Japan [Patients with DED are vulnerable to ocular discomfort and irritation, burning sensation, itching, and blurred vision [In this study, both 1% and 2% rebamipide clear solutions and placebo significantly improved all signs and symptoms except Schirmer 1 test in the efficacy assessment after 12 weeks of treatment. When studying the effect of topical eye drops, a vehicle that resembles tear substitutes could improve signs and symptoms of patients. Nevertheless, in this study, rebamipide clear solution showed the effect of significantly improving TBUT, Schirmer 1 test, and corneal fluorescein staining compared to the placebo group.