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

University of California San Francisco (UCSF)

Status and phase: Not yet enrolling; Phase 4

Conditions: Pupil Reaction Absent; Dilation

Treatments: Device: MydCombi Device; Drug: MydCombi Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT06366217

20-32530A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

MydCombi

Experimental group

Description:

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

Treatment:

Drug: MydCombi Drug

Device: MydCombi Device

Standard of Care

No Intervention group

Description:

Participants will receive the standard of care dilation: tropicamide 1% and phenylephrine 2.5%