Purchase this article with an account.
A. Komuro, S. Shinoda, K. Oshiden, S. Kinoshita; The Efficacy and Safety of Rebamipide (OPC-12759) Ophthalmic Suspension in the Treatment of Dry Eye. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6269.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To investigate the efficacy and safety of 1% and 2% rebamipide ophthalmic suspension compared with placebo (PBO) in patients with dry eye.
A multicenter, randomized, double-masked, parallel-group study. Patients with signs and symptoms of dry eye (n=308, mean age 55.2 years) were randomized (1:1:1) to 1% or 2% rebamipide, or PBO groups, and administered one drop in each eye four times daily for 4 weeks. The primary objective endpoint was fluorescein corneal staining (FCS). Secondary objective endpoints were lissamine green conjunctival staining (LGCS), tear film breakup time (TBUT) and the Schirmer test. Subjective endpoints included dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain and blurred vision) and subject’s impression. Baseline characteristics were similar in all groups; all 308 randomized patients were included in the statistical analysis.
Both 1% and 2% rebamipide were significantly more effective than PBO in terms of the change from baseline (CFB) to the end of treatment with last observation carried forward (LOCF) in FCS (p<0.01), LGCS (p<0.01), and TBUT (p<0.05) scores, except for Schirmer test values. In the severe dry eye population, as defined by baseline FCS scores, 2% rebamipide was more effective than 1% rebamipide in improving FCS. CFB to LOCF for all five dry eye-related ocular symptoms and subject’s impression scores showed significant improvements with 2% rebamipide versus PBO (p<0.05). No deaths or treatment-related serious adverse events occurred in any treatment group. The incidence of ocular safety abnormalities was similar across the rebamipide and PBO groups.
Rebamipide was effective in treating both signs and symptoms of dry eye patients, and 2% rebamipide was more effective than 1% rebamipide. Results from safety assessments were not clinically meaningful.
Clinical Trial: :
www.clinicaltrials.gov NCT00475319, Japan
This PDF is available to Subscribers Only