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

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