Status:
COMPLETED
Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation
Lead Sponsor:
Eyenovia Inc.
Conditions:
Mydriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Ability to provide signed written consent prior to participation in any study-related procedures.
- Ability to return for the study treatment visit.
- Photopic screening pupil diameter ≤ 3.5 mm in each eye.
- Females not of childbearing potential or negative pregnancy test
Exclusion
- Pregnant or Lactating
- Clinically significant abnormalities of the eye
- Active eye disease
- Using medication that can effect pupil dilation
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06217796
Start Date
November 28 2023
End Date
January 9 2024
Last Update
April 18 2024
Active Locations (1)
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1
SUNY
New York, New York, United States, 10036