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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Ocular Hypertension, Open Angle-glaucoma

Intervention / Treatment
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* Drug: ONO-9054
* Drug: Latanoprost


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm 1<br>ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days. | Drug: ONO-9054<br> <br> |
| Active Comparator: Active Comparator Arm 2<br>Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days. | Drug: Latanoprost<br> <br> * Other names: Xalatan®;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-9054, ocular hypertension (OHT), Open angle-glaucoma (OAG), Glaucoma, Eye Diseases, Mild to moderate