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OpenTrials
Completed

NCT Number: NCT06217796

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

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

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Key information

Conditions

Mydriasis Eye Diseases Pupil Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SUNY

New York, 10036, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MydCombi

Combination Product

A single metered spray administered with the MydCombi dispenser

Other names: tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%

Primary outcomes

  1. Mean Change in Pupil Diameter

    Time frame: 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 outcomes

  1. 6.0 mm or Greater at 30 Minutes

    Time frame: 30 minutes

    Percentage of eyes achieving pupil diameter of 6.0 mm or greater

  2. 7.0 mm or Greater at 30 Minutes

    Time frame: 30 minutes

    Percentage of eyes achieving pupil diameter of 7.0 mm or greater

  3. Distribution of Pupil Diameters

    Time frame: 360 minutes

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

Sponsors and collaborators

Lead sponsor

Eyenovia Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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