A Small-Volume Topical Ophthalmic Spray for Pupillary Dilation in Children

Abstract

Purpose To evaluate the noninferiority of mydriatic eye drops administered through a commercially available spray (Optejet; Eyenovia, Inc) compared with standard eye drops on pupillary dilation in children. Design Prospective, randomized, single-masked clinical trial. Participants Children 18 years of age or younger requiring pupillary dilation as part of a scheduled eye examination. Methods Pupillary mydriasis with phenylephrine 2.5% and tropicamide 1% administered via standard eye drops compared with an automated microdosing spray device. Main Outcome Measures Noninferiority of change in maximum pupil diameter and change in pupillary constriction percentage 30 minutes after dilation. Results One hundred thirty-four eyes of 67 participants were included in the final analysis, with 67 eyes randomized to eye drops and 67 eyes randomized to spray. Mean ± standard deviation age was 8.8 ± 3.44 years, 60% were male, and 80% of eyes had dark irides. Spherical equivalent refractive error and baseline pupillary characteristics were similar between groups. Maximum pupil diameter was 7.65 mm (95% confidence interval [CI], 7.45–7.85 mm) in the eye drop group and 7.72 mm (95% CI, 7.54–7.90 mm) in the spray group. Change in maximum pupil diameter was 2.15 mm (95% CI, 1.96–2.35 mm) in the eye drop group and 2.48 mm (95% CI, 2.09–2.87 mm) in the spray group. Change in pupillary constriction percentage was –30.29% (95% CI, –33.03% to –27.55%) for eye drops and –32.29% (95% CI, –34.87% to –29.70%) for spray. Compared with eye drops, the spray met noninferiority criteria for maximum pupil diameter and pupillary constriction percentage. Sixty-seven percent of participants preferred spray over eye drops. Conclusions Our study demonstrated that an ophthalmic spray containing 1% tropicamide and 2.5% phenylephrine was noninferior to traditional eye drops for maximum pupil diameter and pupillary constriction percentage. Further work is needed to characterize the cycloplegic properties of this route of administration. Ophthalmic sprays have the potential to increase the acceptability of pupillary dilation in children while maintaining a similar mydriatic effect as eye drops. Financial Disclosure(s) The author(s) have no proprietary or commercial interest in any materials discussed in this article.