Evaluation of Pupil Dilation Speed With the MAP Dispenser

Phase 4 Completed 61 enrolled Eyenovia Inc.

RandomizedCrossoverDouble-blindDiagnostic

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

Timeline

Start: 2021-05-24
Primary completion: 2021-06-03
Completion: 2021-06-03

Outcome

Met primary endpoint

paper The treatment group difference of one spray of TR-PH FC was noninferior to two sprays (p < 0.001). PMID 37158245 ↗

Publications

Chayet A, Ramirez A, Scott B, Whitcomb J, Lam P, Ianchulev T. Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet(R). Ther Deliv. 2023 Feb;14(2):93-103. doi: 10.4155/tde-2022-0061. Epub 2023 May 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phenylephrine	Small molecule	0.008 ml	Topical
Subject	Phenylephrine	Small molecule	0.016 ml	Topical
Subject	tropicamide	Small molecule	0.008 ml	Topical
Subject	tropicamide	Small molecule	0.016 ml	Topical

Indications

No indication recorded.