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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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06366217
Study type Interventional
Source University of California, San Francisco
Contact Julius Oatts, MD
Phone 415-353-2289
Email Julius.Oatts@ucsf.edu
Status Not yet recruiting
Phase Phase 4
Start date May 1, 2024
Completion date December 31, 2024

See also
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Completed NCT05134974 - Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) Phase 3
Completed NCT04620213 - Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis Phase 3
Completed NCT05274321 - Efficacy of the Nanodropper Device on Pupillary Dilation N/A
Completed NCT05223478 - Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects Phase 3
Completed NCT04024891 - Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis Phase 2