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

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Notable Primary endpoint(s) modified Show 7 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2024 to Jul 7, 2025
    • Results posted: Sep 22, 2026
    • Completed without a posted recruiting period
    • Final enrollment: 70 participants (planned 100)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 3 words
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Primary and study completion dates changed from estimate of Dec 31, 2024 to Jul 7, 2025v4 Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Trial status: Not Yet Recruiting to Completed
    • Enrollment target: estimated 100 to confirmed 70
    • Start date changed from estimate of Sep 30, 2024 to Oct 1, 2024
    • Secondary endpoint revised
  4. Notable Start date: May 1, 2024 to Sep 30, 2024v3
  5. Notable Primary endpoints revised (3)
    • Secondary endpoint revised
    • Eligibility criteria expanded, about 1 word
    v2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06366217
Lead Sponsor University of California, San Francisco
Conditions
(from sponsor)
Dilation, Pupil Reaction Absent
Related terms Dilatation, Pathologic, Pupil Disorders
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov