Phase 4
Completed N=30
Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation
Mydriasis
Source: ClinicalTrials.gov NCT06217796 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Mean Change in Pupil Diameter — 3.73; 6.46 millimeters
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.
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 | — |
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. Informational only — not medical advice.