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

Dilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366217
• Other study ID #: 20-32530A
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Julius Oatts, MD
• Phone: 415-353-2289
• Email: Julius.Oatts[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Dilation
• Mydriasis

Intervention

Device:
• MydCombi Device
ophthalmic spray

Drug:
• MydCombi Drug
Tropicamide 1% and phenylephrine HCl 2.5%

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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