Phase 4
N=30
Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation
Mydriasis
Bottom Line
View on ClinicalTrials.gov: NCT06217796 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Mean Change in Pupil Diameter — 3.73; 6.46 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MydCombi (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eyenovia Inc.
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Pupil Diameter |
3.73; 6.46 | — |
| SECONDARY 6.0 mm or Greater at 30 Minutes |
67.2 | — |
| SECONDARY 7.0 mm or Greater at 30 Minutes |
43.1 | — |
| SECONDARY Distribution of Pupil Diameters |
2.73; 4.80; 6.46; 6.95; 6.70; 6.09 | — |
Summary
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Pregnant or Lactating
- Clinically significant abnormalities of the eye
- Active eye disease
- Using medication that can effect pupil dilation
Data sourced from ClinicalTrials.gov (NCT06217796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.