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 Details — Status: Completed

Administrative data

• NCT number: NCT06217796
• Other study ID #: EYN-MYD-TP-41PM
• Status: Completed
• Phase: Phase 4
• Start date: November 28, 2023
• Est. completion date: January 9, 2024

Study information

• Verified date: February 2024
• Source: Eyenovia Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mydriasis

Intervention

Combination Product:
• MydCombi
A single metered spray administered with the MydCombi dispenser

Locations

Country	Name	City	State
United States	SUNY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eyenovia Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 minutes
Secondary	6.0 mm or Greater at 30 Minutes	Percentage of eyes achieving pupil diameter of 6.0 mm or greater	30 minutes
Secondary	7.0 mm or Greater at 30 Minutes	Percentage of eyes achieving pupil diameter of 7.0 mm or greater	30 minutes
Secondary	Distribution of Pupil Diameters	Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes	360 minutes