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Abstract
BackgroundRebamipide with mucin secretagogue activity was recently approved for the treatment of dry eye. The efficacy and safety in the treatment of rebamipide were shown in two pivotal clinical trials. It was the aim of this study to evaluate the effect of 2 % rebamipide ophthalmic suspension in patients with dry eye and analyze relevant factors for favorable effects of rebamipide in clinical practice.MethodsThis was a retrospective cohort study of 48 eyes from 24 patients with dry eye treated with 2 % rebamipide ophthalmic suspension. Dry eye-related symptom score, tear film break-up time (TBUT), fluorescein ocular surface staining score (FOS) and the Schirmer test were used to collect the data from patients at baseline, and at 2, 4, 8, and 12 week visits. To determine the relevant factors, multiple regression analyses were then performed.ResultsMean dry eye-related symptom score showed a significant improvement from the baseline (14.5 points) at 2, 4, 8 and 12 weeks (9.80, 7.04, 7.04 and 7.83 points, corrected P value <0.001, respectively). Median FOS showed a significant improvement from the baseline (3.0 points) at 2, 4, 8 and 12 weeks (2.0, 2.0, 1.0 and 1.0 points, corrected P value <0.001, respectively). TBUT and Schirmer test values were not significantly improved after the treatment. For ocular symptoms, three parameters (foreign body sensation, dry eye sensation and ocular discomfort) showed significant improvements at all visits. The multiple regression analyses showed that the fluorescein conjunctiva staining score was significantly correlated with the changes of dry eye-related symptom score at 12 weeks (P value = 0.017) and dry eye-related symptom score was significantly correlated with independent variables for the changes of FOS at 12 weeks (P value = 0.0097).ConclusionsTwo percent rebamipide ophthalmic suspension was an effective therapy for dry eye patients. Moreover the fluorescein conjunctiva staining score and dry eye-related symptom score might be good relevant factors for favorable effects of rebamipide.Electronic supplementary materialThe online version of this article (doi:10.1186/s12886-015-0040-0) contains supplementary material, which is available to authorized users.
Highlights
Rebamipide with mucin secretagogue activity was recently approved for the treatment of dry eye
The tear film has been traditionally reported to consist of three important components: a mucin layer that coats the ocular surface epithelium, an aqueous layer that is present between the mucin and a lipid layer, and a lipid layer that overlays the surface of the tear film [7]
The therapeutic effects of rebamipide ophthalmic suspension are considered to be due to the increase of corneal and conjunctival mucin, and its safety and efficacy have been established in clinical trials and some experimental reports
Summary
This was a retrospective case series study. All participants in this study were Japanese individuals recruited from the Department of Ophthalmology at the Kobe University Hospital in Japan. Patients with three essential problems, which were dry eye-related symptoms, abnormality of tear stability or secretion, and ocular surface damage were regarded as suffering from dry eye. Fluorescein ocular surface staining (FOS), TBUT measurement, Schirmer’s test and interviews related to subjective dry eye symptoms were performed as far as possible at every visit. Relevant factors for the changes of dry eye related symptom scores and fluorescein ocular surface staining score from baseline to 12 weeks were assessed. Secondary endpoints were TBUT, Schirmer’s test measurement (without topical anesthesia), fluorescein staining score in cornea or conjunctiva, and each parameter score of subjective dry eye symptom on each occasion. Repeated measures analysis of variances or Friedman test were appropriately used to analyze overall trend in the changes of the parameter throughout the present study
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