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Lyle M. Bowman, Kamran Hosseini; Safety of Bromfenac Formulated in DuraSite on Ocular Tissues. Invest. Ophthalmol. Vis. Sci. 2011;52(14):476.
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The purpose of this study was to investigate the ocular toxicity and safety of bromfenac formulated in DuraSite across ocular tissues.
Male and female Dutch-Belted rabbits were assigned to 4 groups (3/sex/group). Vehicle control and concentrations of 0.045%, 0.09%, or 0.18% were tested. One drop of each test formulation or vehicle was instilled into the left eye of each animal b.i.d. The right eye served as a control. All animals were dosed for a period of 14 days and sacrificed on day 15 .Data was evaluated for compound effects included mortality and moribundity, clinical observations, body weights, body weight changes, food consumption, twice-daily macroscopic examinations, microscopic ophthalmic examination, intraocular pressures, clinical pathology, gross necropsy findings, organ weights, and ocular histopathology.
No test article related effects were observed from clinical observations or body weight data. There were no significant changes in food consumption or IOP changes with no morbidity. Macroscopic ocular findings were not toxicologically meaningful. Ophthalmic examinations showed no suspected test article related findings. There were no compound-related changes in the urinalysis data, necropsy findings or organ weights. Ocular histopathologic examination showed no evidence of scleral or intraocular inflammation, degeneration, or thinning.
Ocular instillation of DuraSite eye drop formulation with bromfenac concentrations ranging from 0.045% to 0.18% to Dutch-Belted rabbits twice-daily for 14 days elicited no evidence of ocular irritation or systemic toxicity and no dose-related effects on specific ocular indices.
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