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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye spray called MydCombi to determine if it works as well as regular eye drops for dilating pupils during eye exams. The goal is to make the process quicker and easier for eye doctors and patients. The trial seeks participants who regularly undergo dilation in both eyes as part of their routine eye care. Individuals with pupil-related issues or certain health conditions affecting the eyes may not be eligible. As a Phase 4 trial, MydCombi is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I need to stop my current medications for the MydCombi trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for MydCombi?

Research shows that MydCombi, a mix of two medicines, is generally safe for enlarging pupils. This treatment has approval for short-term use to dilate pupils. In earlier studies, 94% of eyes reached the desired size of 6 mm within 35 minutes of using the spray.

Most people tolerate MydCombi well, with no serious side effects reported. The treatment involves a quick spray in the eye, differing slightly from traditional eye drops but designed to be equally safe and effective. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about MydCombi because it offers a new way to dilate pupils using an ophthalmic spray, which is different from the standard of care that typically involves drops. This spray combines tropicamide 1% and phenylephrine HCl 2.5%, the same active ingredients used in traditional eye drops, but delivers them in a quick, easy-to-use spray. This method could make the process faster and more comfortable for patients, potentially improving their overall experience during eye exams.

What evidence suggests that MydCombi is effective for dilated pupil?

Research has shown that MydCombi, a combination of tropicamide and phenylephrine, effectively enlarges pupils. One study found that 94% of eyes treated with MydCombi achieved pupil dilation to 6mm or more within 35 minutes, surpassing the 78% success rate of regular eye drops. In this trial, participants will receive either MydCombi or the standard dilation care. Other studies have found that a single dose of MydCombi is as effective as multiple doses of regular drops. This suggests that MydCombi works quickly and effectively, potentially making eye exams faster and more convenient. ^{1 5 6 7 8}

Who Is on the Research Team?

Julius Oatts, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06366217

Efficacy of the MydCombi on Pupillary Dilation in Pediatric ... 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03751631

Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1 ... This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PE) vs. phenylephrine (PE) alone and tropicamide ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3974293/

Randomized Clinical Trial on the Efficacy and Side Effects ... To compare the efficacy and side effects of two combinations of tropicamide and phenylephrine as mydriatics for ophthalmoscopy.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37158245/

Pupil dilation evaluation of two mydriatic dosing profiles ... Conclusion: A single microdose was noninferior to two microdoses of TR-PH FC and achieved clinically significant mydriasis in a timely manner. ...

5. empr.com empr.com/home/news/fixed-dose-combo-mydcombi-ophthalmic-spray-approved-to-induce-mydriasis/

Fixed-Dose Combo Mydcombi Ophthalmic Spray Approved ... Additionally, 94% of eyes administered Mydcombi achieved 6mm or greater dilation at 35 minutes post-instillation compared with 78% of eyes ...

6. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dbff7eeb-a16a-4106-ae5e-4effdd33cc45

MYDCOMBI- tropicamide and phenylephrine hydrochloride ... MYDCOMBI provided a clinically significant effect in the proportion of eyes achieving pupil diameter of ≥ 6 mm at 35-minute post-dose in 94% of eyes compared to ...

7. fda.gov fda.gov/media/172967/download

Statistical Review and Evaluation: MydCombi (Tropicamide ... MydCombi (Tropicamide 1%/ Phenylephrine HCl 2.5%) Ophthalmic Spray ... spray (two sprays within 5 minutes) for dilation of the pupil.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06217796

Study Details | NCT06217796 | Safety and Efficacy of Fixed ... MydCombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. The approved dose is 1 ...