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Brian C. Gilger, Jacklyn H. Salmon, David A. Wilkie, Terah Webb, Mike Peel; An Aqueous Calcineurin Inhibitor, Scy-641, Is As Effective As Cyclosporine In The Treatment Of Naturally-occurring Keratoconjunctivitis Sicca In Dogs. Invest. Ophthalmol. Vis. Sci. 2012;53(14):580.
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To compare the efficacy of an aqueous calcineurin inhibitor, SCY-641, and 1% cyclosporine in the treatment of spontaneous, naturally occurring immune-mediated keratoconjunctivitis sicca (KCS) in dogs.
A randomized, blinded, placebo-controlled, clinical study of 56 days duration was performed in dogs with immune-mediated KCS assigned to treatment with topical twice-daily aqueous calcineurin-inhibitor solution (SCY-641), 1% cyclosporine in oil (CsA), or artificial tears (AT) by the study administrator. Dogs entered into the study were either previously untreated or had a washout period of at least 7 days. Clinical examination and schirmer tear tests (STT) were performed prior to therapy and at Days 7, 14, 28, and 56 after initiation of treatment.
Thirty dogs were enrolled in the study. No adverse effects were noted with any treatment and all treatments appeared to be well-tolerated. There were no significant differences in STT values in dogs of the 3 groups prior to therapy (Day 0; mean STT 8.7 +/- 2.3 mm/min) or after 7 days of treatment. However, at day 14, STT values in dogs treated with CsA (mean STTv24.1 +/- 5.3 mm/min), was significantly higher than the STT in dogs treated with SCY-641 (mean STT 17.4 +/- 5.0 mm/min) (Student’s t test; P=0.001), which in turn was significantly higher than STT in dogs treated with AT (mean STT 11.0 +/- 7.5 mm/min) (Student’s t test; P=0.003). By day 28 and at day 56, there were no significant differences between STT of dogs treated with CsA (mean STT 23.8 +/- 3.8 mm/min; 23.0 mm/min) or SCY-641 (mean STT 18.2 +/- 5.4 mm/min; 17.7 +/-7.1 mm/min), while both groups had STT higher than the AT treated group.
SCY-641 was well tolerated by dogs with naturally occurring KCS. By 14 days, dogs treated with SCY-641 had significantly higher STT than placebo treated dogs and by 28 days STT values in dogs treated with SCY-641 were not significantly different than dogs treated with standard-of-care topical CsA. These results indicate that topical SCY-641 is as efficacious in a spontaneous model of KCS as topical CsA. Further evaluation of SCY-641 is warranted for treatment of canine and human immune-mediated KCS.
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