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Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation

Mydriasis Clinical Trial

Official title:
A Single-Center, Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution (Mydcombi®) Administered With the Mydcombi Dispenser for Pupil Dilation (THE MIST-2.1 STUDY)

Clinical Trial Summary

Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.

Clinical Trial Description

MydCombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. The approved dose is 1 metered spray to the cornea of each eye to be dilated to be repeated after 5 minutes. This study will define the dilation of the pupil with ½ of the approved dose - a single metered spray to the cornea of each eye. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06217796
Study type Interventional
Source Eyenovia Inc.
Contact
Status Completed
Phase Phase 4
Start date November 28, 2023
Completion date January 9, 2024
View Details
See also
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Completed NCT04024891 - Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis Phase 2