NCT06217796

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Eyenovia Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Mydriasis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MydCombi	A single metered spray administered with the MydCombi dispenser

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-01-09
• Completion: 2024-01-09
• First posted: 2024-01-22
• Last updated: 2024-04-18
• Results posted: 2024-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study