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J. Heaton, J.W. Hiddemen, R.B. Hackett, R.L. Rice, M.M. Gruebbel; Ocular Effects of Nepafenac Ophthalmic Suspension Following Six Months of Topical Ocular Administration to Pigmented Rabbits . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2650.
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Purpose:To determine the ocular irritation and systemic toxicity potential of nepafenac ophthalmic suspensions when dosed 3 times/day to pigmented rabbits for 6 months. Methods: Five groups of 14 animals received 2 drops of 0 (vehicle), 0.3, 1 or 1.5% Nepafenac Ophthalmic Suspension in the right eye 3 times daily for 6 months. An additional group of rabbits was maintained as an Untreated Control group. Clinical signs, body weights, ocular findings and clinical pathology were assessed during the study. At completion of the study, ocular tissues and major organs were submitted for histopathological examination. Results: No adverse treatment–related clinical signs or body weight changes were observed. Biomicroscopy revealed no significant treatment–related findings. Indirect ophthalmoscopic evaluations determined that all animals remained within normal limits during the study. Statistical analyses of the pachymetry, intraocular pressure, specular microscopy, clinical pathology and organ weight measurements revealed no findings attributed to topical ocular treatment with nepafenac suspensions. Microscopic evaluation of the ocular tissues and major organs revealed no evidence of ocular or systemic toxicity. Conclusions: Over a 6 month period, daily topical ocular application of 0.3% to 1.5% suspensions of nepafenac produced no significant ocular findings and no ocular or systemic toxicity.
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