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

NCT06366217 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DEVICE

MydCombi Device

ophthalmic spray

DRUG

MydCombi Drug

Tropicamide 1% and phenylephrine HCl 2.5%

Sponsors & Collaborators

Principal Investigators

  • Julius Oatts, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06366217 on ClinicalTrials.gov