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P.C. Donshik, G. Foulks, M. Monica, P. Zhang, A. Tano, S. Nakatsu, S. Bramer; Multicenter, Randomized, Double–Masked, Dose–Response, Placebo–Controlled, Parallel–Group Study of the Safety and Efficacy of Rebamipide (OPC–12759) Sterile Ophthalmic Suspension in the Treatment of Dry Eye . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2037.
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Purpose: To evaluate the safety and efficacy of rebamipide ophthalmic suspension 0.5%, 1% and 2% for the treatment of dry eye. Methods: This was a multicenter, randomized, double–masked, dose–response, placebo–controlled, parallel–group study that evaluated the safety and efficacy of multiple doses of Rebamipide ophthalmic suspension instilled into both eyes for 12 weeks. After a two week run–in period a total of 200 subjects with signs and symptoms of dry eyes were randomized to 4 treatment groups. The primary objective endpoint was fluorescein corneal staining (FCS). Secondary objective endpoints included lissamine green conjunctival staining (LGCS) and Schirmer’s test. The primary subjective endpoint was the subject’s primary ocular discomfort (POD), defined as the subject's most bothersome symptom, identified at screening. Severity of individual dry–eye– related ocular symptoms and the subject's overall treatment impression at week 12 were secondary subjective endpoint. Results: Compared to placebo at week 12, subjects taking 2% rebamipide showed superiority (p–value<0.05) or favorable trend (p–value<0.1) in mean change from baseline (CFB) for 1)FCS score (p=0.076; p=0.015 at week 6). 2)POD (p=0.044). 3) LGCS (p=0.070). and 4) the individual symptom severity scores of gritty/sandy sensation (p=0.015), burning/pain (p–0.003) as well as the overall treatment impression scores (p=0.044). The 2% rebamipide group was statistically superior to placebo group in mean CFB for Schirmer's test at Week 2(p=0.002) and Week 8 (p=0.034). The safety profile of rebamipide was favorable. No deaths or treatment–related SAE were reported. The incidence of treatment–related eye disorders in the rebamipide treatment groups was less than the incidence of treatment–related eye disorders in the placebo group. Results from other safety assessments were not clinically meaningful. Conclusions: All three concentrations of rebamipide ophthalmic suspension were well–tolerated and efficacy was demonstrated in dry eye subjects. The concentration of 2% rebamipide appears to be the most effective concentration. There were no serious safety issues in this trial.
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