High-precision piezo-ejection ocular microdosing: Phase II study on local and systemic effects of topical phenylephrine
Therapeutic Delivery 2018 DOI: 10.4155/tde-2017-0095 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Masked, nonrandomized, crossover study Peer reviewed |
|---|---|
| Sample size | 12 |
| Population | Human subjects |
| Intervention | Phenylephrine |
| Dose | 8 µl (microdosing), 32 µl (eyedropper) |
| Topics | Microdosing |
| Key points | Piezoelectric microdosing of 10% phenylephrine achieved comparable pupil dilation to a 10% eyedropper with significantly lower systemic absorption and less eye irritation. |
Abstract
Aim: Conventional eyedropper-delivered volumes (25-50 µl) exceed the eye's usual tear-film volume (7 µl) and precorneal reservoir capacity, risking overflow and ocular/systemic complications. Piezoelectric high-precision microdosing may circumvent these limitations. Results & methodology: In this masked, nonrandomized, cross-over study, subjects (n = 12) underwent pupil dilation with topical phenylephrine (PE) administered by 32-µl eyedropper (2.5% or 10% formulation) and 8-µl electronic microdosing (10% formulation). Microdosing with PE-10% achieved comparable peak dilation as 10% eyedropper-delivery and superior dilation to 2.5% eyedropper-delivery (p = 0.009) at 75 min. Microdosing significantly reduced 20-min plasma PE levels versus PE10% eyedropper; neither treatment altered heart rate/blood pressure. Eye irritation occurred significantly less frequently with microdosing than PE10% eyedrops.
Conclusion: Piezo-ejection PE microdosing achieves comparable biological effect as eyedropper dosing; reduced systemic absorption may decrease risk of systemic side effects.
Comparable studies
Other non-randomized and open-label trials on microdosing, most cited first.