Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ono Pharma USA Inc
Criteria
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