A Small Volume Topical Ophthalmic Spray for Pupillary Dilation in Children: A Randomized, Masked Non-inferiority Trial.
Publication/Presentation Date
12-1-2025
Abstract
PURPOSE: To evaluate the non-inferiority of mydriatic eye drops administered through a commercially available spray (Optejet, Hyperion DeFi, Inc.) compared to standard eye drops on pupillary dilation in children.
DESIGN: Prospective, randomized, single-masked clinical trial PARTICIPANTS: Children ≤18 years of age or under requiring pupillary dilation as part of their scheduled eye examination.
INTERVENTION: Pupillary mydriasis with phenylephrine 2.5% and tropicamide 1% administered via standard eye drops compared to an automated microdosing spray device.
MAIN OUTCOME MEASURES: Non-inferiority of change in maximum pupil diameter and change in pupillary constriction percentage 30 minutes after dilation.
RESULTS: 134 eyes of 67 participants were included in the final analysis, with 67 eyes randomized to eye drops and 67 eyes randomized to spray. Mean 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%CI 7.45 to 7.85 mm) in the eye drop group and 7.72 mm (7.54 to 7.90 mm) in the spray group. Change in maximum pupil diameter was 2.15 mm (1.96 to 2.35 mm) in the eye drop group and 2.48 mm (2.09 to 2.87 mm) in the spray group. Change in pupillary constriction percentage was --30.29% (-33.03 to -27.55%) for eye drops and -32.29% (-34.87 to -29.70%) for spray. Compared to eye drops, the spray met non-inferiority criteria for maximum pupil diameter and pupillary constriction percentage. 67% of participants preferred spray over eye drops.
CONCLUSION: Our study demonstrated that an ophthalmic spray containing 1% tropicamide and 2.5% phenylephrine was non-inferior 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.
ISSN
1549-4713
Published In/Presented At
Godfrey, A., Menon, S., Takla, P., Lu, J., Chen, T., Bass, O., Brown, M., Indaram, M., & Oatts, J. T. (2025). A Small Volume Topical Ophthalmic Spray for Pupillary Dilation in Children: A Randomized, Masked Non-inferiority Trial. Ophthalmology, S0161-6420(25)00745-6. Advance online publication. https://doi.org/10.1016/j.ophtha.2025.11.009
Disciplines
Medicine and Health Sciences | Pediatrics
PubMedID
41338301
Department(s)
Department of Pediatrics
Document Type
Article