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

Phase 4

Not yet recruiting

• Conditions: Pupil Reaction Absent; Dilation
• Interventions: Device: MydCombi Device; Drug: MydCombi Drug

• Registration Number: NCT06366217
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-15
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-19
• Study Start: 2024-05-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MydCombi	MydCombi Drug	Patients will be dilated using MydCombi drug: (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray in one eye for a few seconds once
MydCombi	MydCombi Device	Patients will be dilated using MydCombi drug: (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray in one eye for a few seconds once

Primary Outcome Measures

Name	Time	Method
Percent Change in pupil constriction percentage	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
Percent change in Spherical equivalent	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.
Percent Change in maximum pupil diameter	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Intraocular Pressure	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States