December 2002
Volume 43, Issue 13
ARVO Annual Meeting Abstract  |   December 2002
Safety and Systemic Exposure of Gatifloxacin 0.5% Ophthalmic Solution in Dogs
Author Affiliations & Notes
  • TR Carpenter
    Allergan Inc Irvine CA
  • C Vangyi
    Allergan Inc Irvine CA
  • C Zerouala
    LAB Pre-Clinical Intl Inc Quebec City PQ Canada
  • M Carrier
    LAB Pre-Clinical Intl Inc Quebec City PQ Canada
  • B Short
    Allergan Inc Irvine CA
  • B Brar
    Allergan Inc Irvine CA
  • Footnotes
    Commercial Relationships    T.R. Carpenter, Allergan E; C. Vangyi, Allergan E; C. Zerouala, LAB Pre-Clinical Intl. E; M. Carrier, LAB Pre-Clinical Intl. E; B. Short, Allergan E; B. Brar, Allergan E.
Investigative Ophthalmology & Visual Science December 2002, Vol.43, 1581. doi:
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    • Get Citation

      TR Carpenter, C Vangyi, C Zerouala, M Carrier, B Short, B Brar; Safety and Systemic Exposure of Gatifloxacin 0.5% Ophthalmic Solution in Dogs . Invest. Ophthalmol. Vis. Sci. 2002;43(13):1581.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract: : Purpose:Gatifloxacin is a novel, broad spectrum, 4th generation fluoroquinolone antibiotic being developed for the treatment of ocular bacterial infections. We assessed ocular and systemic toxicity following topical ophthalmic administration of gatifloxacin in beagle dogs. Methods:Beagle dogs (n = 48) received 2 drops of ophthalmic gatifloxacin 0.5% or placebo in the right eye either 10 times daily for 1 month, or on a variable dose schedule of 32 times daily for 2 days, then 16 times daily for 5 days, then 4 times daily for the remainder of 3 months. 8 dogs/group were analyzed at the end of treatment; the remaining animals were analyzed after a 1 month recovery period. Results:There was no evidence of toxicity on ocular clinical signs, slit lamp biomicroscopy, indirect ophthalmoscopy, pupillary reflex, nor on intraocular pressure. There were no drug-related systemic effects as assessed by clinical signs, body weight, hematology, clinical chemistry, urinalysis, organ weight, or histopathology. Plasma Cmax values following the final daily dose among dogs treated 10 times/day on day 7 (73.7 ng/mL) and day 28 (65.0 ng/mL) were comparable. Conclusion:Topical ophthalmic gatifloxacin 0.5% administered to dogs for up to 3 months with as many as 32 applications daily did not produce ocular or systemic toxicity.

Keywords: 319 antibiotics/antifungals/antiparasitics • 390 drug toxicity/drug effects • 316 animal model 

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