Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet®
| Autor: | Arturo Chayet, Angeles Ramirez, Beth Scott, Julie Whitcomb, Peter Lam, Tsontcho Ianchulev |
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| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Therapeutic Delivery. 14:93-103 |
| ISSN: | 2041-6008 2041-5990 |
| Popis: | Aim: To compare pupil dilation achieved by a single microdose versus two microdoses of tropicamide-phenylephrine fixed combination (TR-PH FC) delivered by the Optejet®. Patients & methods: In this assessor-masked, crossover, noninferiority study, 60 volunteers underwent two treatment visits and received either one (∼8 μl) or two sprays (∼16 μl) of TR-PH FC to both eyes in randomly assigned order. Results: At 35 min postdose, mean change in pupil diameter was 4.6 mm and 4.9 mm following one or two sprays, respectively. The estimated treatment group difference was -0.249 mm (standard error: 0.036; 95% CI: -0.320, -0.177). No adverse events were reported. Conclusion: A single microdose was noninferior to two microdoses of TR-PH FC and achieved clinically significant mydriasis in a timely manner. Clinical Trial Registration: NCT04907474 ( ClinicalTrials.gov ) |
| Databáze: | OpenAIRE |
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