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