A Phase 4 interventional study of MydCombi Device and MydCombi Drug in Dilation and Pupil Reaction Absent, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Health services research
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.
120 studies on the registry are indexed under Dilatation, Pathologic; 18 are open to participants now.
This study's enrollment of 70 is below the median of 82 across 84 interventional studies indexed under Dilatation, Pathologic.
Browse Dilatation, Pathologic studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will be dilated using MydCombi drug: (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray in one eye for a few seconds once
Device: MydCombi Device · Drug: MydCombi Drug
Participants will receive the standard of care dilation: tropicamide 1% and phenylephrine 2.5%
ophthalmic spray
Tropicamide 1% and phenylephrine HCl 2.5%
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.
Time frame: Before dilation and 30 minutes after dilation
Pupil Constriction Percentage
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum
Time frame: Before and 30 minutes after dilation
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.
Time frame: Before dilation and 30 minutes after dilation
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.
Time frame: Before and 30 minutes After Dilation
Patients 18 years of age or under requiring pupillary dilation as part of their scheduled eye examination at the UCSF pediatric ophthalmology clinic between October 2024 and July 2025 were enrolled.
| Milestone | Spray | Drops |
|---|---|---|
| Started | 70 | 70 |
| Completed | 67 | 67 |
| Not completed | 3 | 3 |
| Withdrew: Did not complete study activities | 3 | 3 |
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.
| mm | Drops Before Dilation | Drops After Dilation | Drops Change Score | Spray Before Dilation | Spray After Dilation | Spray Change Score |
|---|---|---|---|---|---|---|
| Maximum Pupil Diameter | 5.49 (5.27 to 5.72) | 7.65 (7.45 to 7.85) | 2.15 (1.96 to 2.35) | 5.24 (4.87 to 5.62) | 7.72 (7.54 to 7.90) | 2.48 (2.09 to 2.87) |
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum
| percentage | Drops Before Dilation | Drops After Dilation | Drops Change Score | Spray Before Dilation | Spray After Dilation | Spray Change Score |
|---|---|---|---|---|---|---|
| Pupil Constriction Percentage | 37.42 (34.62 to 40.22) | 7.13 (5.61 to 8.66) | -30.29 (-33.03 to -27.55) | 37.55 (34.83 to 40.28) | 5.27 (4.25 to 6.29) | -32.29 (-34.87 to -29.70) |
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.
| Diopters | Drops Before Dilation | Drops After Dilation | Drops Change Score | Spray Before Dilation | Spray After Dilation | Spray Change Score |
|---|---|---|---|---|---|---|
| Spherical Equivalent | -1.40 (-2.44 to -0.36) | -0.98 (-2.10 to 0.15) | 0.34 (-0.16 to 0.85) | -1.04 (-1.89 to -0.19) | -0.40 (-1.29 to 0.49) | 0.65 (0.23 to 1.06) |
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.
| millimeters of mercury | Drops Before Dilation | Drops After Dilation | Drops Change Score | Spray Before Dilation | Spray After Dilation | Spray Change Score |
|---|---|---|---|---|---|---|
| Intraocular Pressure | 15.91 (14.99 to 16.83) | 17.61 (16.37 to 18.86) | 1.68 (0.59 to 2.78) | 16.40 (15.43 to 17.36) | 17.27 (16.08 to 18.47) | 0.92 (-0.12 to 1.96) |
Collected over From enrollment until end of follow up at the end of the office visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spray | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Drops | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
Each participant had 2 eyes enrolled in the study. One eye was randomized to the MydCombi "Spray" and the other was assigned the standard of care "Drops". One participant had insufficient data and was not included in the analysis. Number is counted in participants.
| Age, Categorical(Eyes) | Spray | Drops | Total |
|---|---|---|---|
| <=18 years | 67 | 67 | 134 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Eyes) | Spray | Drops | Total |
|---|---|---|---|
| Female | 27 | 27 | 54 |
| Male | 40 | 40 | 80 |
| Race and Ethnicity Not Collected(Participants) | Spray | Drops | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Myopia(Eyes) | Spray | Drops | Total |
|---|---|---|---|
| Count of units | 43 | 43 | 86 |
| Hyperopia(Eyes) | Spray | Drops | Total |
|---|---|---|---|
| Count of units | 24 | 24 | 48 |
| Spherical Equivalence(Diopters) | Spray | Drops | Total |
|---|---|---|---|
| Mean | -1.04 ± 3.54 | -1.40 ± 4.27 | -1.22 ± 3.91 |
| Maximum pupil diameter(mm) | Spray | Drops | Total |
|---|---|---|---|
| Mean | 5.24 ± 1.57 | 5.49 ± 0.95 | 5.37 ± 1.30 |
| Constriction percentage(Percent of constriction) | Spray | Drops | Total |
|---|---|---|---|
| Mean | 37.55 ± 11.39 | 37.42 ± 11.70 | 37.49 ± 7.97 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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