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

Phase 4

Completed

• Conditions: Mydriasis
• Interventions: Combination Product: MydCombi

• Registration Number: NCT06217796
• Lead Sponsor: Eyenovia Inc.

Brief 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.

Study Timeline

• Study Start: 2023-11-28
• Study First Submitted: 2024-01-04
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-22
• Status Verified: 2024-02
• Results First Submitted: 2024-03-22
• Results First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Results First Posted: 2024-04-18
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Treatment	MydCombi	Single metered spray

Primary Outcome Measures

Name	Time	Method
Mean Change in Pupil Diameter	30 minutes	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

Secondary Outcome Measures

Name	Time	Method
6.0 mm or Greater at 30 Minutes	30 minutes	Percentage of eyes achieving pupil diameter of 6.0 mm or greater
Distribution of Pupil Diameters	360 minutes	Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes
7.0 mm or Greater at 30 Minutes	30 minutes	Percentage of eyes achieving pupil diameter of 7.0 mm or greater

Trial Locations

Locations (1)

SUNY; 🇺🇸 New York, New York, United States