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M. Tomsic, M. Gekkieva, A. Weichselberger, N.C. Yannoulis; Evaluation of Pimecronlimus Tablets 30 mg Bid for the Treatment of Dry Eye in Primary Sjögren’s Syndrome Patients . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2025.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To evaluate the efficacy and safety of pimecrolimus tablets (30 mg bid) as compared to placebo on keratoconjunctivitis sicca (KCS) in patients with primary Sjögren’s syndrome (pSS). Methods: This was a prospective, randomized, double–masked, placebo–controlled, parallel–group, multi–center proof–of–concept trial. pSS patients with at least moderate signs and symptoms of KCS were randomized to pimecrolimus or placebo bid for 12 weeks. Results: Thirty–eight patients (19 pimecrolimus; 19 placebo) completed the 12–week treatment period according to protocol. For both corneal staining (Oxford Grading Scheme, 0–5 scale) and the composite ocular symptoms score (average of three ratings 0–4 for sandiness/grittiness, itching, and burning/pain), greater mean decreases from baseline were observed in the pimecrolimus group than in the placebo group at all 3 visits where efficacy was assessed. For the reduction in corneal staining, the mean difference vs placebo at Week 12 was –0.45 score units in favor of pimecrolimus (P=0.2833). For the reduction in composite ocular symptoms score, the mean difference vs placebo at Week 12 was –0.26 score units, again in favor of pimecrolimus (P=0.4025). Numerically favorable results with pimecrolimus were also observed for tear–film break–up time, Schirmer’s test, and the investigators’ and patients’ global assessments of dry eye and pSS conditions. Results of the safety assessments conducted during the 12–week double–masked treatment period and a follow–up visit performed one year after discontinuation of therapy, indicate pimecrolimus 30 mg bid was safe and well tolerated. Conclusions: The results of this exploratory study are suggestive of a favorable treatment effect with pimecrolimus 30 mg bid on the signs and symptoms of KCS in patients with pSS, albeit statistical significance was not reached due to the limited sample size of the study. Further evaluation of the potential effect of pimecrolimus for the treatment of KCS appears to be warranted.
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