Résumé : | SIGNIFICANCE: After a dilated eye examination, many patients experience symptoms of prolonged light sensitivity, blurred vision, and cycloplegia associated with pharmacological mydriasis. Phentolamine mesylate ophthalmic
solution (PMOS) may expedite the reversal of mydriasis in patients, potentially facilitating return to functional vision and reducing barriers to obtaining dilated eye examinations.
PURPOSE: The protracted reversal time after pharmacologically induced pupil dilation impairs vision. We tested
the hypothesis that PMOS rapidly reduces pupil diameter in this acute indication.
METHODS: In this double-masked placebo-controlled, randomized, two-arm crossover phase 2b trial, we evaluated
the effects of one drop of 1% PMOS applied bilaterally in subjects who had their pupils dilated by one of two common
mydriatic agents: 2.5% phenylephrine or 1% tropicamide. End points included change in pupil diameter, percent
of subjects returning to baseline pupil diameter, and accommodative function at multiple time points.
RESULTS: Thirty-one subjects completed the study (15 dilated with phenylephrine and 16 with tropicamide).
Change in pupil diameter from baseline at 2 hours after maximal dilation with 1% PMOS was −1.69 mm and
was significantly greater in magnitude compared with placebo for every time point beyond 30 minutes (P < .05).
At 2 hours, a greater percentage of study eyes given 1% PMOS returned to baseline pupil diameter compared with
placebo (29 vs. 13%, P = .03), which was this also seen at 4 hours (P < .001). More subjects treated with PMOS in
the tropicamide subgroup had at least one eye returning to baseline accommodative amplitude at 2 hours (63 vs.
38%, P = .01). There were no severe adverse events, with only mild to moderate conjunctival hyperemia that resolved in most patients by 6 hours.
CONCLUSIONS: Phentolamine mesylate ophthalmic solution at 1% reversed medically induced pupil dilation
more rapidly than placebo treatment regardless of which mydriatic was used (adrenergic agonists and cholinergic
blockers) with a tolerable safety profile. |