A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)

Status:	Completed
Conditions:	High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	18 - 85
Updated:	4/21/2016
Start Date:	May 2014

A 28-day Double-masked, Randomized, Parallel-group, Active Controlled Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)

The primary objectives of this study are to compare the safety, tolerability, and mean
change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to
latanoprost 0.005% following ocular instillation once every evening for 28 days.

Inclusion Criteria:

- Male or female aged 18-85 (inclusive) with confirmed diagnosis of OHT or OAG

- Confirmed diagnosis of bilateral OHT or mild to moderate chronic OAG

- Able to undergo washout of all ocular drugs

- An IOP ≥ 24 mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least 1 eye; but < 36
mmHg in both eyes at both Day -5 and Day 1

- Central corneal thickness 500-620 µm at screening and Day -5 in both eyes

- Best corrected visual acuity (BCVA) of +0.7 Log Mar or better

Exclusion Criteria:

- Any history of severe ocular trauma in either eye at any time

- History of angle closure or ocular laser surgery within the past 3 months or any
refractive surgery procedure within the past 6 months of Screening Visit in the study
eye(s)

- Cataracts that prevent observation or photography of the fundus in either eye

We found this trial at

sites

Newport Beach Clinical Site

Newport Beach, California 92663

from

Newport Beach, CA