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

Eyenovia Inc.30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Mydriasis

Interventions

MydCombiCOMBINATION_PRODUCT

A single metered spray administered with the MydCombi dispenser

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to provide signed written consent prior to participation in any study-related procedures. * Ability to return for the study treatment visit. * Photopic screening pupil diameter ≤ 3.5 mm in each eye. * Females not of childbearing potential or negative pregnancy test Exclusion Criteria: * Pregnant or Lactating * Clinically significant abnormalities of the eye * Active eye disease * Using medication that can effect pupil dilation

Locations (1)

SUNY

New York, New York, United States

Outcomes

Primary Outcomes

Mean Change in Pupil Diameter

Mean change in pupil diameter at 30 minutes from the time of drug dose versus baseline, as measured by digital pupillometry in highly photopic conditions

Time frame: 30 minutes

Secondary Outcomes

6.0 mm or Greater at 30 Minutes

Percentage of eyes achieving pupil diameter of 6.0 mm or greater

Time frame: 30 minutes

7.0 mm or Greater at 30 Minutes

Percentage of eyes achieving pupil diameter of 7.0 mm or greater

Time frame: 30 minutes

Distribution of Pupil Diameters

Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes

Time frame: 360 minutes

Data from ClinicalTrials.gov

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