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

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)

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

Study Overview

• Status: Completed
• Conditions: Mydriasis
• Intervention / Treatment: Combination product: MydCombi

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10036
      • SUNY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open Label Treatment; Single metered spray	Combination product: MydCombi; A single metered spray administered with the MydCombi dispenser; Other Names: tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eyenovia Inc.
• Investigators: Study Director: Greg Bennett, MS, Eyenovia Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): January 9, 2024
• Study Completion (Actual): January 9, 2024

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mydriasis
• Additional Relevant MeSH Terms: Eye Diseases; Pupil Disorders; Mydriasis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline; Tropicamide
• Other Study ID Numbers: EYN-MYD-TP-41PM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD may be shared in aggregate. PHI will neither be shared nor collected by the database.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes