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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06366217
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Dilation
  • Pupil Reaction Absent

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MydCombi Device — DEVICE
    ophthalmic spray
  • MydCombi Drug — DRUG
    Tropicamide 1% and phenylephrine HCl 2.5%

Study Details

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.

Key Dates

Start date
Sep 30, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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
  • No Intervention: Standard of Care
    Participants will receive the standard of care dilation: tropicamide 1% and phenylephrine 2.5%

Primary Outcome Measure

Percent change in Spherical equivalent [ Time Frame: Before dilation and 30 minutes after dilation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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University of California, San Francisco· San Francisco, CA