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

20-32530A

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.

2024-05-01

2024-12-31

2024-12-31

Not yet recruiting

Early phase I

100

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-04-19