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A Small-Volume Topical Ophthalmic Spray for Pupillary Dilation in Children: A Randomized, Masked, Noninferiority
Alyssa Godfrey1, Shreya Menon2, Patrick Takla2
1Drexel University College of Medicine, Philadelphia, Pennsylvania.
Insights
Ophthalmic spray containing tropicamide and phenylephrine demonstrated non-inferior pupillary dilation compared to eye drops in children. This new spray delivery method may improve patient acceptance for pediatric eye exams.
Area of Science:
- Ophthalmology
- Clinical Pharmacology
- Drug Delivery Systems
Background:
- Pupillary dilation is essential for comprehensive pediatric eye examinations.
- Traditional eye drops can be challenging to administer to children.
- Novel drug delivery systems aim to improve patient experience and compliance.
Purpose of the Study:
- To evaluate the non-inferiority of a mydriatic ophthalmic spray compared to standard eye drops for pupillary dilation in children.
- To assess the efficacy of a spray-based tropicamide and phenylephrine formulation.
Main Methods:
- A prospective, randomized, single-masked clinical trial was conducted.
- Participants included children aged 18 years or younger requiring pupillary dilation.
- Mydriasis was induced using phenylephrine 2.5% and tropicamide 1% via standard eye drops or an automated microdosing spray device.
Main Results:
- The study included 134 eyes from 67 participants.
- The ophthalmic spray achieved non-inferiority to eye drops in terms of maximum pupil diameter and pupillary constriction percentage.
- A significant majority (67%) of participants preferred the spray over traditional eye drops.
Conclusions:
- Ophthalmic spray delivery of tropicamide and phenylephrine is non-inferior to eye drops for achieving mydriasis in children.
- Ophthalmic sprays offer a potentially more acceptable method for pupillary dilation in pediatric populations.
- Further research is warranted to fully characterize the cycloplegic effects of spray administration.
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.
