Conditions: Ocular Hypertension Open-Angle Glaucoma
Keywords: Ocular Hypertension Open-Angle Glaucoma POAG Glaucoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 191
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Part 3: MGV354 ophthalmic suspension, 1 drop in both eyes once per day for 7 days arm 2: Part 3: MGV354 placebo, 1 drop in both eyes once per day for 7 days

Interventions: intervention 1: MGV354 ophthalmic suspension intervention 2: MGV354 placebo
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as placebo comparator

Protocol document: