Phase 4
Completed N=61
Evaluation of Pupil Dilation Speed With the MAP Dispenser
Mydriasis
Source: ClinicalTrials.gov NCT04907474 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Mean Change in Pupil Diameter From Baseline — 4.55; 4.88 millimeters
◆ Published Evidence
Emerging
3citations · ~1 / year
Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet<sup>®</sup>.
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
Linked Publications
-
Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet<sup>®</sup>.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Pupil Diameter From Baseline |
4.55; 4.88 | — |
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) and the linked publication. 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.