Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet®
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).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
Therapeutic delivery - 14(2023), 2 vom: 07. Feb., Seite 93-103 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Chayet, Arturo [VerfasserIn] |
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| Links: |
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| Themen: |
1WS297W6MV |
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| Anmerkungen: |
Date Completed 12.05.2023 Date Revised 04.06.2023 published: Print-Electronic ClinicalTrials.gov: NCT04907474 Citation Status MEDLINE |
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| doi: |
10.4155/tde-2022-0061 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM356613518 |
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| 500 | |a ClinicalTrials.gov: NCT04907474 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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) | ||
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