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

Sponsor

Ono Pharmaceutical Co. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT02083289

Collaborator

(none)

123

Enrollment

Locations

Arms

10.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Open Angle-glaucoma	Drug: ONO-9054 Drug: Latanoprost	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Arm 1 ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.	Drug: ONO-9054
Active Comparator: Active Comparator Arm 2 Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.	Drug: Latanoprost Other Names: Xalatan®

Arm

Intervention/Treatment

Experimental: Experimental Arm 1

ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.

Drug: ONO-9054

Active Comparator: Active Comparator Arm 2

Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.

Drug: Latanoprost

Other Names:

Xalatan®

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles Clinical Site	Los Angeles	California	United States	90048
2	Mission Hills Clinical Site	Mission Hills	California	United States	91345
3	Newport Beach Clinical Site	Newport Beach	California	United States	92663
4	Pasadena Clinical Site	Pasadena	California	United States	91105
5	Petaluma Clinical Site	Petaluma	California	United States	94954
6	Morrow Clinical Site	Morrow	Georgia	United States	30260
7	Roswell Clinical Site	Roswell	Georgia	United States	30076
8	New York Clinical Site	New York	New York	United States	10029
9	High Point Clinical Site	High Point	North Carolina	United States	27262
10	Cranberry Township Clinical Site	Cranberry Township	Pennsylvania	United States	16066
11	Philadelphia Clinical Site	Philadelphia	Pennsylvania	United States	19104
12	Austin Clinical Site	Austin	Texas	United States	78731