NCT02743780

A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma

A Three Part, First-in-human, Randomized, Double-masked, Placebo-Controlled, Safety, Tolerability and Early Efficacy Study of MGV354 in Healthy Subjects and in Patients With Ocular Hypertension or Glaucoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

Part 1 will evaluate the safety and tolerability of single ascending doses of MGV354 compared to placebo in healthy male and female subjects. Part 2 will evaluate the safety and tolerability of MGV354 in a multiple ascending dose design (two highest tolerated doses from Part 1) compared to placebo when administered for 7 days to patients with ocular hypertension or glaucoma. Part 3 will explore the safety, tolerability and efficacy of a single dose level of MGV354 (maximum tolerated dose) compared to placebo when administered for 7 days in patients with ocular hypertension or glaucoma.

Conditions

• Ocular Hypertension
• Open-Angle Glaucoma

Interventions

Type	Name	Description
DRUG	MGV354 ophthalmic suspension
DRUG	MGV354 placebo	Inactive ingredients used as placebo comparator

Timeline

• Start date: 2016-03-02
• Primary completion: 2016-09-20
• Completion: 2016-09-20
• First posted: 2016-04-19
• Last updated: 2018-07-02
• Results posted: 2017-08-31