A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma

Phase 1/2 Completed 191 enrolled Alcon Research Novartis Institutes for BioMedical Research · collab

RandomizedParallel-groupDouble-blindOther

Summary

The purpose of this study is to determine if the clinical profile of topical-ocular MGV354 merits further development for the indication of lowering intraocular pressure (IOP).

Timeline

Start: 2016-03-02
Primary completion: 2016-09-20
Completion: 2016-09-20

Outcome

Missed primary endpoint

paper Overall, MGV354 0.1% demonstrated no statistically significant effect compared to vehicle in lowering IOP based on the study's main outcome measure. PMID 29802818 ↗

Publications

Stacy R, Huttner K, Watts J, Peace J, Wirta D, Walters T, Sall K, Seaman J, Ni X, Prasanna G, Mogi M, Adams C, Yan JH, Wald M, He Y, Newton R, Kolega R, Grosskreutz C. A Randomized, Controlled Phase I/II Study to Evaluate the Safety and Efficacy of MGV354 for Ocular Hypertension or Glaucoma. Am J Ophthalmol. 2018 Aug;192:113-123. doi: 10.1016/j.ajo.2018.05.015. Epub 2018 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MGV354	Unknown	0.1 %	Topical