Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366217
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-10
Brief Title:
Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None