Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217796
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2024-01-04
Brief Title:
Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation
Sponsor:
Eyenovia Inc
Organization:
Eyenovia Inc
Study Overview
Official Title:
A Single-Center Open Label Phase 4 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 25-Tropicamide 1 Ophthalmic Solution Mydcombi Administered With the Mydcombi Dispenser for Pupil Dilation THE MIST-21 STUDY
Status:
COMPLETED
Status Verified Date:
2024-02
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:
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose
Detailed Description:
MydCombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired The approved dose is 1 metered spray to the cornea of each eye to be dilated to be repeated after 5 minutes This study will define the dilation of the pupil with ½ of the approved dose - a single metered spray to the cornea of each 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?:
None
Is an FDA AA801 Violation?:
None