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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ono Pharmaceutical Co. Ltd
• Treatments: Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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