Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MydCombi Device, MydCombi Drug.
- Who it may be relevant to
- Registry conditions: Dilation, Pupil Reaction Absent. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Device MydCombi Device
ophthalmic spray - Drug MydCombi Drug
Tropicamide 1% and phenylephrine HCl 2.5%
Primary outcome measures
- Percent change in Spherical equivalent [Time frame: Before dilation and 30 minutes after dilation]
- Percent Change in maximum pupil diameter [Time frame: Before dilation and 30 minutes after dilation]
- Percent Change in pupil constriction percentage [Time frame: Before and 30 minutes after dilation]
Secondary outcome measures (1)
- Percent Change in Intraocular Pressure [Time frame: Before and 30 minutes After Dilation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Publications
- Godfrey A, Menon S, Takla P, Lu J, Chen T, Bass O, Brown M, Indaram M, Oatts JT. A Small-Volume Topical Ophthalmic Spray for Pupillary Dilation in Children: A Randomized, Masked, Noninferiority Trial. Ophthalmology. 2026 Apr;133(4):515-521. doi: 10.1016/j.ophtha.2025.11.009. Epub 2025 Dec 1. PMID 41338301
Identifiers
NCT: NCT06366217 · 20-32530A