MydCombi for Dilated Pupil

Overseen By Julius Oatts, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Disqualifiers: Pupillary abnormality, Anterior segment abnormality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Julius Oatts, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for both kids and adults who need their pupils dilated as part of regular eye care. It's not for those with abnormal pupils or eye segments, or health issues that stop pupils from dilating.

Inclusion Criteria

My eyes are being dilated as part of my routine eye care.

Exclusion Criteria

I have an eye condition affecting my pupil or the front part of my eye.

I cannot have my pupils dilated due to a health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive MydCombi in one eye and standard of care dilation in the other eye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pupil constriction, spherical equivalent, and intraocular pressure

30 minutes

1 visit (in-person)

Treatment Details

Interventions

• MydCombi

Trial Overview The study tests MydCombi, a new way to dilate pupils using a microdose dispenser. It aims to show it's just as good as standard drops but faster and more accurate for patient care in clinics.

Participant Groups

Group I: MydCombi Experimental Treatment 2 Interventions

Patients will be dilated using MydCombi drug: (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray in one eye for a few seconds once

Group II: Standard of Care Active Control 1 Intervention

Participants will receive the standard of care dilation: tropicamide 1% and phenylephrine 2.5%

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+