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

Phase 2

Completed

• Conditions: Ocular Hypertension; Open Angle-glaucoma
• Interventions: Drug: ONO-9054; Drug: Latanoprost

• Registration Number: NCT02083289
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-11
• Study Start: 2014-05
• Primary Completion: 2014-12
• Status Verified: 2016-01
• Disposition First Submitted: 2016-01-26
• Disposition First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Disposition First Posted: 2016-02-25
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm 1	ONO-9054	ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.
Active Comparator Arm 2	Latanoprost	Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.

Primary Outcome Measures

Name	Time	Method
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
Mean change in diurnal IOP (average of four time points) from baseline	28 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Pasadena Clinical Site; 🇺🇸 Pasadena, California, United States

New York Clinical Site; 🇺🇸 New York, New York, United States

Morrow Clinical Site; 🇺🇸 Morrow, Georgia, United States

High Point Clinical Site; 🇺🇸 High Point, North Carolina, United States

Philadelphia Clinical Site; 🇺🇸 Philadelphia, Pennsylvania, United States

Austin Clinical Site; 🇺🇸 Austin, Texas, United States

Los Angeles Clinical Site; 🇺🇸 Los Angeles, California, United States

Newport Beach Clinical Site; 🇺🇸 Newport Beach, California, United States

Petaluma Clinical Site; 🇺🇸 Petaluma, California, United States

Roswell Clinical Site; 🇺🇸 Roswell, Georgia, United States

Cranberry Township Clinical Site; 🇺🇸 Cranberry Township, Pennsylvania, United States

Mission Hills Clinical Site; 🇺🇸 Mission Hills, California, United States