Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06366217

Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients

To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dilation Dilatation, Pathologic Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pupil Disorders Pupil Reaction Absent Signs and Symptoms

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

The proposed study strives to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard-of-care (SOC) eye drops in a randomized trial.

Primary Aim: Demonstrate non-inferiority of using MydCombi to achieve pupillary dilation compared to standard-of-care eye drops in patients.

Participants 2 years or older undergoing standard pupillary dilation will be randomized to use MydCombi in one eye and standard of care pupillary dilation in another eye.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Receiving pupillary dilation in both eyes as part of the participant's standard of care.

Exclusion criteria

  • Pupillary or anterior segment abnormality
  • Participants with pre-existing health conditions that would prevent pupillary dilation.

Treatment and study plan

MydCombi Device

Device

ophthalmic spray

MydCombi Drug

Drug

Tropicamide 1% and phenylephrine HCl 2.5%

Primary outcomes

  1. Percent change in Spherical equivalent

    Time frame: Before dilation and 30 minutes after dilation

    Cycloplegia is the paralysis of the ciliary muscle of the eye resulting in dilatation of the pupil and paralysis of accommodation.

    Cycloplegia is defined as the "change score." Change scores were calculated by subtracting the spherical equivalent value after dilation from the value before dilation for each eye.

  2. Percent Change in maximum pupil diameter

    Time frame: Before dilation and 30 minutes after dilation

    The pupil is the opening in the center of the iris (the structure that gives particpant's eyes their color). The diameter is a straight line passing from side to side through the center of the pupil, which is shaped like a circle.

  3. Percent Change in pupil constriction percentage

    Time frame: Before and 30 minutes after dilation

    Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum

Secondary outcomes

  1. Percent Change in Intraocular Pressure

    Time frame: Before and 30 minutes After Dilation

    Intraocular pressure is the pressure, or force, inside of the participants eyes. Specifically, it's a measurement of the fluid pressure in the participant's aqueous humor.

Study contacts

Contact information is provided by the study sponsor or research team.

Julius Oatts, MD

CONTACT

[email protected]

415-353-2289

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Sep 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.