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

NCT06366217 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 20-32530A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dilation; Pupil Reaction Absent

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Percent Change in Intraocular Pressure

  Before and 30 minutes After Dilation

Study Arms (2)

MydCombi

EXPERIMENTAL

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; Drug: MydCombi Drug

Standard of Care

NO INTERVENTION

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

Interventions

MydCombi Device DEVICE

ophthalmic spray

MydCombi

MydCombi Drug DRUG

Tropicamide 1% and phenylephrine HCl 2.5%

MydCombi

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Dilatation, Pathologic; Pupil Disorders

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms

Study Officials

• Julius Oatts, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julius Oatts, MD

CONTACT

415-353-2289; Julius.Oatts@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: September 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)