@article{138a4caa157746a1b8d1ffae65be32f9,
title = "Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: Pooled randomized Phase III trials",
abstract = "Design: Prospective, double-masked, controlled, cross-over superiority studies. Materials & methods: Eligible volunteers in two pooled Phase III trials received microdosed mydriatics. MIST-1 study subjects received fixed-combination TR-PH, phenylephrine 2.5% (PH) or tropicamide 1% (TR). MIST-2 study subjects received TR-PH or placebo. Mean change from baseline in pupil diameter was measured by digital pupillometry at 35 min postadministration. Results: Pooled efficacy analysis included 131 subjects. Compared with TR-PH, treatment group difference in 35-min change in mean pupil dilation from baseline was 0.58 mm (p < 0.0001) with TR, 3.87 mm (p < 0.0001) with PH and 4.65 mm (p < 0.0001) with placebo. Adverse events reported were infrequent, transient and mostly mild. Conclusion: TR-PH demonstrated superior pupil dilation compared with each component and placebo. TR-PH was safe & well-tolerated.",
keywords = "microdose, mydriasis, phenylephrine, pupillary dilation, tropicamide",
author = "Wirta, {David L.} and Walters, {Thomas R.} and Flynn, {William J.} and Siddarth Rathi and Tsontcho Ianchulev",
note = "Funding Information: This research was sponsored by Eyenovia, Inc., New York, NY. DL Wirta was a clinical investigator for Eyenovia, and is a consultant to Alcon, Allergan, Annexon, Eyenovia, InSite, Kala, Nicos, Novartis, Ocugen, Ocular Therapeutix, Ora, Orasis and Santen. TR Walters was a clinical investigator for Eyenovia and consultant to Allergan, Eyenovia, InSite, Nicox and Ocular Therapeutix. WJ Flynn was a clinical investigator for Eyenovia and consultant to Alcon, Allergan Bausch Health, Equinox, Eyenovia, Glaukos, Nicox, Ora, Orasis, OysterPoint, Santen and Surface Pharma. S Rathi was the Medical Monitor for both studies for Eyenovia and consultant to Warby Parker and Verana Health. T Ianchulev is the CEO and Chief Medical Officer for Eyenovia, Inc and is named on the microdose dispenser patent application. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: {\textcopyright} 2021 Future Medicine Ltd.. All rights reserved.",
year = "2021",
month = mar,
doi = "10.4155/tde-2021-0011",
language = "English",
volume = "12",
pages = "201--214",
journal = "Therapeutic Delivery",
issn = "2041-5990",
publisher = "Future Science",
number = "3",
}