Completed

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)

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What is being tested

MydCombi

Combination Product
Who is being recruted

Eye Diseases

+ Pupil Disorders

+ Mydriasis

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 4
Interventional
Study Start: November 2023
See protocol details

Summary

Principal SponsorEyenovia Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 28, 2023

Actual date on which the first participant was enrolled.

This study focuses on testing a medicine called MydCombi, which is used to make the pupils of the eyes larger, a process known as mydriasis. This is important for eye exams and other diagnostic procedures where doctors need a better view inside the eye. The study is particularly interested in finding out if using half the usual dose of MydCombi, which is just one spray per eye instead of two, is still effective for pupil dilation. This research might help improve patient comfort and reduce medication use during eye examinations. Participants in the study will receive a single spray of MydCombi directly onto the cornea of each eye. The goal is to observe how well the pupils dilate with this reduced dosage. Although no specific outcomes are listed, the study will likely monitor the degree and duration of pupil dilation and any side effects that may occur. This approach aims to establish whether a lower dose can still achieve the desired dilation safely and effectively.

Official TitleA 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)
NCT06217796
Principal SponsorEyenovia Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesPupil DisordersMydriasis

Criteria

4 inclusion criteria required to participate
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

4 exclusion criteria prevent from participating
Pregnant or Lactating

Clinically significant abnormalities of the eye

Active eye disease

Using medication that can effect pupil dilation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Single metered spray

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

SUNY

New York, United StatesOpen SUNY in Google Maps
CompletedOne Study Center