CompletedPhase 4

Evaluation of Pupil Dilation Speed With the MAP Dispenser

Mexico61 participantsStarted 2021-05-24

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Mean Change in Pupil Diameter From Baseline

Timeframe: 35 minutes post drug administration

Trial details

NCT IDNCT04907474

SponsorEyenovia Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-03

Results submitted2022-06-07

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