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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2024-01-09

Brief Summary

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

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Detailed Description

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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.

Conditions

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Mydriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects receive the same intervention

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Open Label Treatment

Single metered spray

Group Type OTHER

MydCombi

Intervention Type COMBINATION_PRODUCT

A single metered spray administered with the MydCombi dispenser

Interventions

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MydCombi

A single metered spray administered with the MydCombi dispenser

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%

Eligibility Criteria

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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