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Meta-Analysis
. 2025 May 27;25(1):317.
doi: 10.1186/s12886-025-04146-0.

Safety and efficacy of rebamipide compared to artificial tears for the treatment of dry eye: a systematic review and meta-analysis

Ching-Wen Chiu  1   2 , Ka-Wai Tam  3   4   5 , I-Chan Lin  6   7
Affiliations
Meta-Analysis

Safety and efficacy of rebamipide compared to artificial tears for the treatment of dry eye: a systematic review and meta-analysis

Ching-Wen Chiu et al. BMC Ophthalmol. .

Abstract

Background: Rebamipide (RBM) is a novel drug that increases mucin secretion on the ocular surface. Nevertheless, the therapeutic efficacy of topical RBM for dry eye disease (DED) treatment remains inconclusive. Accordingly, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effectiveness of RBM for DED treatment.

Methods: We searched the PubMed, Embase, and Cochrane Library databases for eligible RCTs. The primary outcome was posttreatment changes in tear breakup time (TBUT). We also assessed changes in the values of Schirmer's test (Sch), corneal fluorescein staining scores, and DED-related symptom scores.

Results: We retrieved 12 RCTs with 1368 eyes published during 2012-2023. The results demonstrated that compared with artificial tears, 2% RBM significantly increased the TBUT [standard mean difference (SMD) = 1.42, 95% confidence interval (CI) = 0.20 to 2.64]. Moreover, 2% RBM led to more significant improvements in overall DED-related symptom scores than did artificial tears (SMD = - 1.61, 95% CI = - 2.61 to - 0.61). The differences in the adverse events between the 2% RBM and artificial tears groups were nonsignificant (SMD = 1.23, 95% CI = 0.62 to 2.44).

Conclusion: Topical RBM ophthalmic suspension is a safe and effective treatment for DED patients. Compared to artificial tears, 2% RBM improved TBUT and subjective symptoms of DED. It may be considered as the first-line treatment option for short- TBUT dry eye patients.

Keywords: Dry eye disease; Meta-analysis; Rebamipide; Systematic review; Tear breakup time.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Ethical approval is not required as our study will not include confidential participant data and intervention. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of study selection process
Fig. 2
Fig. 2
Forest plot of changes in TBUT after RBM and artificial tear administration. Values of change are reported with 95% Cis; I2 = 96%
Fig. 3
Fig. 3
Forest plot of changes in LGCS scores after RBM and artificial tear administration. Values of change are reported with 95% Cis; I2 = 100%
Fig. 4
Fig. 4
Forest plot of changes in DED-related symptom scores after RBM and artificial tear administration. Values of change are reported with 95% Cis; I2 = 97%
Fig. 5
Fig. 5
Forest plot of adverse events occurrence after RBM and artificial tear administration. Values of change are reported with 95% Cis; I2 = 33%
See this image and copyright information in PMC

References

    1. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007(2):75–92. 10.1016/s1542-0124(12)70081-2. PMID: 17508116. - PubMed
    1. Chia EM, Mitchell P, Rochtchina E, et al. Prevalence and associations of dry eye syndrome in an older population: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2003;31:229–32. - DOI - PubMed
    1. Schaumberg DA, Sullivan DA, Buring JE, et al. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003;136:318–26. - DOI - PubMed
    1. Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II epidemiology report. Ocul Surf. 2017;15:334–65. - DOI - PubMed
    1. Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015;112:71–82. - PMC - PubMed

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