NCT04907474

Evaluation of Pupil Dilation Speed With the MAP Dispenser

A Study Evaluating Pupil Dilation Speed With the Micro-Array Print (MAP) Dispenser Comparing 2 Dosing Regimens of Tropicamide-Phenylephrine Fixed Combination Ophthalmic Solution

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Eyenovia Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation

Detailed description

After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter. Pupil dilation for each treatment will be compared at each time interval.

Conditions

• Mydriasis

Interventions

Type	Name	Description
DRUG	tropicamide-phenylephrine fixed combination ophthalmic solution	Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis

Timeline

• Start date: 2021-05-24
• Primary completion: 2021-06-03
• Completion: 2021-06-03
• First posted: 2021-05-28
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

1 site across 1 country: Mexico