Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma

Status:	Recruiting
Conditions:	High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	18 - 80
Updated:	3/30/2013
Start Date:	August 2012
Contact:	Brenda Souza
Phone:	609-512-4129

A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma

The primary objective of this study is to evaluate the safety and tolerability of 3 planned
doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension
(OHT) or mild open angle-glaucoma (OAG).

The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the
pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its
tolerability following morning and evening dosing.

Inclusion Criteria:

- Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG

- Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma

- Able to undergo washout of all ocular drugs

- An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; but ≤ 35
mmHg at all time points in both eyes on Day -2 and Day -1

- Central corneal thickness 500-600 µm at screening in both eyes

- BCVA 20/100 or better in both eyes

Exclusion Criteria:

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

- Any history of previous intraocular 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 of the fundus in either eye

We found this trial at

sites

Costa Mesa Clinical Site

Costa Mesa, California 92626

from

Costa Mesa, CA