Ocular Gelfoam Disc-Applicator for Pupillary Dilation in Humans

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Abstract
This study investigates a gelfoam disc device as an alternative topical ophthalmic drug delivery system for pupillary dilation in humans. Gelfoam (Pharmacia & Upjohn) discs were impregnated with 0.60 mg of tropicamide racemate and 1.7 mg of 1-phenylephrine hydrochloride by an ethanol solvent evaporation method. Twenty randomly selected human subjects received baseline examinations, including blood pressure, pulse rate and biomicroscopy of the ocular surface. One impregnated gelfoam disc was placed in the inferior fornix of a randomly selected eye. Simultaneously, the fellow eye was treated with two topically administered drops, one from a phenylephrine hydrochloride 2.5% solution and one from a tropicamide 1% solution. A single, masked observer measured the pupillary diameter in both eyes at various time intervals under constant ambient conditions. Administration of the topical drops was repeated in the fellow eye. At maximum pupillary dilation, the disc was removed, and a post-dilation biomicroscopic exam was performed. Blood pressure and pulse rate were rechecked. The gelfoam-treated eyes' median change in dilation diameter was approximately 25% greater (a two-fold increase in pupillary area) (p< 0.001) at 15.2 min (median time to maximum dilation) than the topically treated fellow eyes. The median change in systolic blood pressure (+1.0 mmHg) and diastolic blood pressure (-1.0 mmHg) was not statistically significant (p>0.1). The average pulse rate was decreased 7 beats per minute (p=0.004). A gelfoam disc may serve as an ophthalmic drug delivery system for pupillary dilation or as a model for other multiple-dose topical drugs.

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