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
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