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

Completed · Phase 2

Conditions studied: Ocular Hypertension, Open Angle-glaucoma

In brief

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.

Key facts

Study ID

NCT02083289

Run by

Ono Pharmaceutical Co., Ltd.

People needed

123

Starts

2014-05-01

Last updated by the study team

2016-02-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Angeles Clinical Site — Los Angeles, California, United States
• Mission Hills Clinical Site — Mission Hills, California, United States
• Newport Beach Clinical Site — Newport Beach, California, United States
• Pasadena Clinical Site — Pasadena, California, United States
• Petaluma Clinical Site — Petaluma, California, United States
• Morrow Clinical Site — Morrow, Georgia, United States
• Roswell Clinical Site — Roswell, Georgia, United States
• New York Clinical Site — New York, New York, United States
• High Point Clinical Site — High Point, North Carolina, United States
• Cranberry Township Clinical Site — Cranberry Township, Pennsylvania, United States
• Philadelphia Clinical Site — Philadelphia, Pennsylvania, United States
• Austin Clinical Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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