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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard of Care | No Intervention | Participants will receive the standard of care dilation: tropicamide 1% and phenylephrine 2.5% |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MydCombi Device | Device | ophthalmic spray |
| |
| MydCombi Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Intraocular Pressure | Intraocular pressure is the pressure, or force, inside of the participants eyes. Specifically, it's a measurement of the fluid pressure in the participant's aqueous humor. | Before and 30 minutes After Dilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julius Oatts, MD | Contact | 415-353-2289 | Julius.Oatts@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Julius Oatts, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41338301 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 9, 2026 | Jan 28, 2026 | 3 | ||
| Mar 13, 2026 |
| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| D011681 | Pupil Disorders |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Drug |
Tropicamide 1% and phenylephrine HCl 2.5% |
|
| Mar 30, 2026 |
| 4 |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |