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

Ono Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Open Angle-glaucoma

Ocular Hypertension

Treatments

Drug: Latanoprost

Drug: ONO-9054

Study type

Interventional

Funder types

Industry

Identifiers

NCT02083289

ONO-9054IOU003

Details and patient eligibility

About

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.

Enrollment

123 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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