DilationPhase 4NCT06366217

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

A Phase 4 study testing MydCombi Device and MydCombi Drug in people with Dilation and Pupil Reaction Absent, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 years and older
Conditions the study is for: Dilation, Pupil Reaction Absent
What is being tested?: MydCombi Device and MydCombi Drug
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2024to 7 Jul 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Receiving pupillary dilation in both eyes as part of the participant's standard of care.

Who cannot join

Pupillary or anterior segment abnormality
Participants with pre-existing health conditions that would prevent pupillary dilation.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

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.

Read the 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.

Conditions: Dilation, Pupil Reaction Absent
Being tested: MydCombi Device, MydCombi Drug
Medical subject headings: Dilatation, Pathologic, Pupil Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MydCombi DeviceDevice
ophthalmic spray
MydCombi DrugDrug
Tropicamide 1% and phenylephrine HCl 2.5%

Study groups in NCT06366217
Study group	Role	What they receive
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 Receives: Device: MydCombi Device; Drug: MydCombi Drug
Standard of Care	No intervention	Participants will receive the standard of care dilation: tropicamide 1% and phenylephrine 2.5%

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: Before dilation and 30 minutes after dilation

Secondary outcomes (1)

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.
Measured: Before and 30 minutes After Dilation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20247 Jul 2025

First posted15 Apr 2024
Study start1 Oct 2024
Primary completion7 Jul 2025
Study completion7 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DilationStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06366217
Sponsor's protocol ID: 20-32530A
Status last verified: Sep 2026
First submitted: 10 Apr 2024
Last updated: 22 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 41338301

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dilation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients
ClinicalTrials.gov ID: NCT06366217
Acronym / sponsor ID: 20-32530A
Conditions: Dilation, Pupil Reaction Absent
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: 1 Oct 2024 (actual)
Primary completion: 7 Jul 2025 (actual)
Study completion: 7 Jul 2025 (actual)
First posted: 15 Apr 2024 (actual)
Results: Posted 22 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MydCombi	Experimental	Device: MydCombi Device, Drug: MydCombi DrugPatients 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%

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Receiving pupillary dilation in both eyes as part of the participant's standard of care.

Key exclusion criteria (2 listed)

Pupillary or anterior segment abnormality
Participants with pre-existing health conditions that would prevent pupillary dilation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MydCombi Deviceophthalmic spray	Device	MydCombi
MydCombi DrugTropicamide 1% and phenylephrine HCl 2.5%	Drug	MydCombi

Primary outcome

Maximum Pupil Diameter
Time frame: Before dilation and 30 minutes after dilation
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.
Pupil Constriction Percentage
Time frame: Before and 30 minutes after dilation
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum
Spherical Equivalent
Time frame: Before dilation and 30 minutes after dilation
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.

1 secondary outcome

Intraocular Pressure
Time frame: Before and 30 minutes After Dilation

Results and safety

Results posted to the registry on 22 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spray	70	67
Drops	70	67

Primary outcome: Maximum Pupil Diameter

Time frame: Before dilation and 30 minutes after dilation. Mean (95% Confidence Interval). Unit: mm

Measure	Drops Before Dilation n = 67	Drops After Dilation n = 67	Drops Change Score n = 67	Spray Before Dilation n = 67	Spray After Dilation n = 67	Spray Change Score n = 67
Value	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)

Population analysed: The spray and drops groups are further split into before and after dilation.

Primary outcome: Pupil Constriction Percentage

Time frame: Before and 30 minutes after dilation. Mean (95% Confidence Interval). Unit: percentage

Measure	Drops Before Dilation n = 67	Drops After Dilation n = 67	Drops Change Score n = 67	Spray Before Dilation n = 67	Spray After Dilation n = 67	Spray Change Score n = 67
Value	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)

Population analysed: The spray and drops groups are further split into before and after dilation.

Primary outcome: Spherical Equivalent

Time frame: Before dilation and 30 minutes after dilation. Mean (95% Confidence Interval). Unit: Diopters

Measure	Drops Before Dilation n = 67	Drops After Dilation n = 67	Drops Change Score n = 67	Spray Before Dilation n = 67	Spray After Dilation n = 67	Spray Change Score n = 67
Value	-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)

Population analysed: The spray and drops groups are further split into before and after dilation.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment until end of follow up at the end of the office visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spray	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Drops	0 of 67 (0%)	0 of 67 (0%)	0 of 67

Limitations and caveats (from the sponsor): Our study population was predominantly composed of children with dark irides, which may limit the generalizability of these results. However, darker irides generally have a slower and smaller response to dilating drops. We measured cycloplegia following administration of tropicamide and phenylephrine, which may not represent broadly used clinical practice for cycloplegia in children.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41338301Godfrey 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julius Oatts, MD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MydCombi Device and MydCombi Drug in people with Dilation and Pupil Reaction Absent, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Pupil Diameter (time frame: Before dilation and 30 minutes after dilation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06366217, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.