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

NCT06217796 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: EYN-MYD-TP-41PM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mydriasis

Keywords

Mydriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 6.0 mm or Greater at 30 Minutes

  30 minutes

• 7.0 mm or Greater at 30 Minutes

  30 minutes

• Distribution of Pupil Diameters

  360 minutes

Study Arms (1)

Open Label Treatment

OTHER

Single metered spray

Combination Product: MydCombi

Interventions

MydCombi COMBINATION_PRODUCT

A single metered spray administered with the MydCombi dispenser

Also known as: tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%

Open Label Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or Lactating
• Clinically significant abnormalities of the eye
• Active eye disease
• Using medication that can effect pupil dilation

Sponsors & Collaborators

• Eyenovia Inc.: lead

Study Sites (1)

SUNY

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Mydriasis

Interventions

Tropicamide

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Greg M. Bennett, VP, Clinical Program Strategy and Development
• Organization: Eyenovia

gbennett@eyenovia.com

833-393-6684

Study Officials

• Greg Bennett, MS

  Eyenovia Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects receive the same intervention

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 22, 2024
• Study Start: November 28, 2023
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)