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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dilation; Pupil Reaction Absent
• Intervention / Treatment: Device: MydCombi Device; Drug: MydCombi Drug

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Julius Oatts, MD; Phone Number: 415-353-2289; Email: Julius.Oatts@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MydCombi; Patients will be dilated using MydCombi drug: (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray in one eye for a few seconds once	Device: MydCombi Device; ophthalmic spray; Drug: MydCombi Drug; Tropicamide 1% and phenylephrine HCl 2.5%
No Intervention: Standard of Care; Participants will receive the standard of care dilation: tropicamide 1% and phenylephrine 2.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in Spherical equivalent	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.	Before dilation and 30 minutes after dilation
Percent Change in maximum pupil diameter	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.	Before dilation and 30 minutes after dilation
Percent Change in pupil constriction percentage	Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum	Before and 30 minutes after dilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Intraocular Pressure	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.	Before and 30 minutes After Dilation

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Julius Oatts, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Pathological Conditions, Anatomical; Dilatation, Pathologic; Mydriasis; Pupil Disorders
• Other Study ID Numbers: 20-32530A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes