May 2004
Volume 45, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2004
SUCCESSFUL TREATMENT OF KERATOCONJUNCTIVITIS SICCA (KCS) IN DOGS WITH PIMECROLIMUS EYE DROPS: A COMPARISON WITH CYCLOSPORIN A (CyA) OPHTHALMIC OINTMENT.
Author Affiliations & Notes
  • R. Ofri
    Koret School of Veterinary Medicine, Hebrew University of Jerusalem, Rehovot, Israel
  • I. Allgoewer
    Veterinary Eye Clinic, Berlin, Germany
  • U. Graenitz
    Veterinary Eye Clinic, Chemnitz, Germany
  • T.M. Pena
    School of Veterinary Medicine, Autonomous University of Barcelona, Barcelona, Spain
  • B.M. Spiess
    School of Veterinary Medicine, University of Zurich, Zurich, Switzerland
  • G.N. Lambrou
    Novartis Institutes for BioMedical Research, Disease Area Ophthalmology, Basel, Switzerland
  • E. Latour
    Novartis Institutes for BioMedical Research, Disease Area Ophthalmology, Basel, Switzerland
  • Footnotes
    Commercial Relationships  R. Ofri, Novartis Pharma AG C; I. Allgoewer, Novartis Pharma AG C; U. Graenitz, Novartis Pharma AG C; T.M. Pena, Novartis Pharma AG C; B.M. Spiess, Novartis Pharma AG C; G.N. Lambrou, Novartis Institutes for BioMedical Research E; E. Latour, Novartis Institutes for BioMedical Research E.
  • Footnotes
    Support  Funded by Novartis Pharma AG
Investigative Ophthalmology & Visual Science May 2004, Vol.45, 69. doi:
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      R. Ofri, I. Allgoewer, U. Graenitz, T.M. Pena, B.M. Spiess, G.N. Lambrou, E. Latour; SUCCESSFUL TREATMENT OF KERATOCONJUNCTIVITIS SICCA (KCS) IN DOGS WITH PIMECROLIMUS EYE DROPS: A COMPARISON WITH CYCLOSPORIN A (CyA) OPHTHALMIC OINTMENT. . Invest. Ophthalmol. Vis. Sci. 2004;45(13):69.

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Abstract

Abstract: : Purpose:The aim of this study was to conduct a clinical trial, testing the efficacy of topical pimecrolimus in alleviating clinical signs of KCS in dogs and compare it with a veterinary commercial form of CyA (Optimmune®). Methods: We conducted an open–label, multicenter, randomized, 8–week study enrolling 44 dogs (77 eyes) previously untreated with CyA. KCS was diagnosed based on a Schirmer Tear Test I (STT) value ≤ 10 mm/min and an aggregate score ≥ 4 in 9 clinical signs of corneal and/or conjunctival inflammation (each sign scored from 0=none to 4=severe). Dogs were randomly assigned to a treatment group, and medicated twice daily with 1% pimecrolimus oil–based drops or 0.2% CyA ointment. Rechecks were conducted at 2, 4 and 8 weeks. Results: Baseline mean STT values in the pimecrolimus and CyA groups were 3.8 ± 0.7 mm/min (mean ± sem; n = 20) and 4.6 ± 0.7 mm/min (n = 24), respectively. Significant improvements were observed within both groups (P ≤ 0.001) within 2 weeks. After 8 weeks, mean increases of 9.2 and 5.8 mm/min were observed in the pimecrolimus and CyA groups, respectively. The difference was marginally significant (P = 0.085). Both drugs also caused a significant improvement in clinical signs of inflammation (P ≤ 0.001) within 2 weeks. Baseline mean total scores in the pimecrolimus and the CyA groups were 16.0 ± 1.1 and 13.9 ± 1.4, respectively. After 8 weeks, there was a significantly larger reduction in the total score in eyes treated with pimecrolimus (mean decrease 10.3) compared to eyes treated with CyA (mean decrease 7.6; P = 0.024). Two dogs from the pimecrolimus group were discontinued due to severe local irritation. Conclusions: The results show that 1% pimecrolimus eye drops are more effective than commercial 0.2% CyA ophthalmic ointment in controlling KCS in dogs. The findings confirm the interest to develop pimecrolimus for treatment of dry eye in humans.

Keywords: cornea: tears/tear film/dry eye • cyclosporine • clinical research methodology 
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