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

Eyenovia

Status and phase: Completed; Phase 4

Conditions: Mydriasis

Treatments: Combination Product: MydCombi

Study type: Interventional

Funder types: Industry

Identifiers

NCT06217796

EYN-MYD-TP-41PM

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Open Label Treatment

Other group

Description:

Single metered spray

Treatment:

Combination Product: MydCombi