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TM Parkinson, E Ferguson, S Febbraro, A Bakhtyari, M Mundasad; Tolerance of Ocular Iontophoresis in Healthy Volunteers . Invest. Ophthalmol. Vis. Sci. 2002;43(13):1854.
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Purpose: Evaluate ocular tolerance of iontophoresis applied to sclera of healthy volunteers using novel hydrogel drug delivery applicators (OcuPhor®) filled with balanced salt solution. Methods: Three-period crossover study in 24 healthy male and female volunteers, 18-43 YO, with visual acuity greater than 20/30. 18 subjects received 0 mA and two of the following iontophoretic currents: 0.1, 0.5, 1, 2, 3, or 4 mA for 20 min; in addition 6 volunteers received 3 mA for 20 min and 0 and 1.5 mA for 40 min. Safety and tolerance were determined by VAS and ophthalmic assessments (slit lamp, visual acuity, funduscopy, tonometry, Ishihara color vision test, and fluorescein staining). Subjects were evaluated before and at intervals up to 24 hr after dosing. Results: OcuPhor applicators were well-tolerated and no clinically significant changes in symptomology or in ophthalmic assessments were seen following exposure to 0-3 mA for 20 min (0-60 mAmin total electric charge). At 4 mA two subjects reported a severe burning sensation under the applicator during dosing; this discomfort persisted for several hours after dosing but resolved by 22 hr post-dose. Some superficial fluorescein staining was observed at 1 hr, but not at 22 hr, post-dose. No further dosing was done at 4 mA. No clinically significant findings were observed following exposure to 1.5 mA for 40 min (60 mAmin total charge). Conclusion: Ocular iontophoresis with the OcuPhor system was safe and well-tolerated at doses as high as 3 mA for 20 min/1.5 mA for 40 min and has promise for noninvasive drug delivery to the eye.
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