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M.O. Price, F.W. Price, Jr.; Effect of Gatifloxacin Ophthalmic Solution 0.3% on Corneal Endothelial Cell Counts in Normal Subjects and in Cataract Surgery Patients . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4935.
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Purpose: To evaluate the effect of gatifloxacin ophthalmic solution 0.3% (ZymarTM, Allergan, Inc.) on corneal endothelial cell count in non–surgical volunteers and in patients undergoing standard cataract surgery. Methods: This single center, open–label clinical study determined the change over time in endothelial cell counts in 2 groups: 20 non–surgical subjects who received gatifloxacin 0.3% and 10 patients who underwent cataract surgery and who received both gatifloxacin 0.3% and ketorolac ophthalmic solution 0.5% (Acular, Allergan, Inc.). Nonsurgical subjects instilled 1 drop of gatifloxacin 0.3% 4 times/day in the left eye for 2 days, and then 1 drop every 10 minutes for 1 hour on the third day. Surgical patients instilled gatifloxacin 0.3% in the eye receiving surgery at a dosing regimen of 1 drop 4 times/day for 2 days, and then 1 drop every 10 minutes for 1 hour on the day of surgery. This group of surgical patients also received 1 drop of ketorolac 0.5% between 10 and 15 minutes afer each dose of gatifloxacin 0.3% during the 2 days prior to surgery and 10 minutes after the last dose of gatifloxacin 0.3% on the day of surgery. Corneal endothelial cells were counted using non–contact specular microscopy at baseline, and at 1 hour after the last dose of gatifloxacin 0.3% in all individuals and also at 3 weeks after the last dose of gatifloxacin 0.3% in non–surgical subjects. Results: Baseline endothelial cell counts (mean ± SD) were 2400 ± 442 in the surgical group and 2520 ± 212 in the non–surgical group. The mean differences from baseline 1 hour after the last dose of gatifloxacin 0.3% were –51 ± 213 (P=0.47) in the surgical group and –7 ± 150 (P=0.84) in the control group. In the non–surgical group, the mean difference from baseline 3 weeks after the last dose was 18 ± 147 (P=0.58). Conclusions: Gatifloxacin ophthalmic solution 0.3% does not have a statistically significant effect on corneal toxicity either in normal subjects or in cataract surgery patients as determinable by endothelial cell counts.
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