TOPLINE:

A novel ophthalmic spray containing 1% tropicamide and 2.5% phenylephrine was noninferior to traditional eye drops for producing changes in the maximum pupil diameter and percentage of pupillary constriction in children, with 67% preferring the spray method over drops.

METHODOLOGY:

• Researchers conducted a clinical trial to evaluate whether a commercial spray that delivered pupil‑dilating medications was noninferior to standard eye drops in children.
• They enrolled 67 children (134 eyes; mean age, 8.8 years; 60% boys) who needed pupil dilation for scheduled eye exams; each eye was randomly assigned to receive either standard drops (one drop each of tropicamide 1% and phenylephrine 2.5%) or Mydcombi spray (two 8-µL sprays of tropicamide 1% and phenylephrine 2.5%).
• The researchers measured pupil size, refraction, and intraocular pressure before and 30 minutes after the administration of medications.
• The primary outcomes were changes in the maximum pupil diameter and percentage of pupillary constriction at 30 minutes.

TAKEAWAY:

• The maximum pupil diameter after dilation was 0.10 mm larger with spray than with drops (95% CI, -0.03 to 0.22 mm), and pupillary constriction was 1.88% points lower with the spray than with drops (95% CI, -3.31 to -0.46); the spray met the prespecified noninferiority criteria for both outcomes.
• Clinically significant poor pupil dilation (≤ 6.0 mm) was observed in only one eye in the spray group and two eyes in the children who received eye drops.
• No adverse effects were observed in either group.
• The majority (67%) of participants preferred the spray over traditional eye drops.

IN PRACTICE:

“Commercially available ophthalmic drop dispensers deliver an average of 30-50 µL per drop; however, the conjunctival sac can only absorb up to 10 µL of fluid, causing excess overflow and medication waste,” the researchers reported.

“Administering ophthalmic medications via small volume spray presents a promising alternative to standard eye drops, potentially improving patient comfort, reducing medical waste, and lowering toxicity,” they added.

SOURCE:

The study was led by Alyssa Godfrey of the Drexel University College of Medicine in Philadelphia. It was published online on December 1, 2025, in Ophthalmology.

LIMITATIONS:

The study population was predominantly composed of children with dark irides. Cycloplegia was assessed after administration of tropicamide and phenylephrine, which may not reflect routine pediatric practice. 

DISCLOSURES:

The study was supported by the National Eye Institute and Eyenovia, Inc. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.