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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02083289

Enrollment

123

Registered

2014-03-11

Start date

2014-05-31

Completion date

Unknown

Last updated

2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle-glaucoma

Keywords

ONO-9054, ocular hypertension (OHT), Open angle-glaucoma (OAG), Glaucoma, Eye Diseases, Mild to moderate

Brief 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.

Interventions

DRUGONO-9054

DRUGLatanoprost

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Mean change in diurnal IOP (average of four time points) from baseline	28 days	—
Evaluating the safety parameters per protocol	28 days	Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations

Secondary

Measure	Time frame
Diurnal IOP	28 days
Mean change from baseline in IOP at each measured time point	28 days
Treatment response rates	28 days
Percent change from baseline in IOP at each measured time point	28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026