Phase 4
N=61
Evaluation of Pupil Dilation Speed With the MAP Dispenser
Mydriasis
Bottom Line
View on ClinicalTrials.gov: NCT04907474 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Mean Change in Pupil Diameter From Baseline — 4.55; 4.88 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tropicamide-phenylephrine fixed combination ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eyenovia Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Pupil Diameter From Baseline |
4.55; 4.88 | — |
Summary
1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation
Eligibility Criteria
Inclusion Criteria
- Photopic screening pupil diameter ≤ 3.5 mm in each eye
Exclusion Criteria
- Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
- Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
- History of closed-angle glaucoma.
- Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
- Ocular surgery or laser treatment of any kind prior to the Screening Visit.
- History of iris trauma, surgery, or atrophy.
- Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.
Data sourced from ClinicalTrials.gov (NCT04907474). 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.