Clinical trial NCT02083289: A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Open Angle-glaucoma
Keywords: ONO-9054
ocular hypertension (OHT)
Open angle-glaucoma (OAG)
Glaucoma
Eye Diseases
Mild to moderate
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2014-03-11
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in diurnal IOP (average of four time points) from baseline
timeFrame: 28 days
measure: Evaluating the safety parameters per protocol
timeFrame: 28 days
Secondary outcomes:
measure: Diurnal IOP
timeFrame: 28 days
measure: Mean change from baseline in IOP at each measured time point
timeFrame: 28 days
measure: Treatment response rates
timeFrame: 28 days
measure: Percent change from baseline in IOP at each measured time point
timeFrame: 28 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Clinical Site
state: California
city: Mission Hills
country: United States
facility: Mission Hills Clinical Site
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Site
state: California
city: Pasadena
country: United States
facility: Pasadena Clinical Site
state: California
city: Petaluma
country: United States
facility: Petaluma Clinical Site
state: California
city: Morrow
country: United States
facility: Morrow Clinical Site
state: Georgia
city: Roswell
country: United States
facility: Roswell Clinical Site
state: Georgia
city: New York
country: United States
facility: New York Clinical Site
state: New York
city: High Point
country: United States
facility: High Point Clinical Site
state: North Carolina
city: Cranberry Township
country: United States
facility: Cranberry Township Clinical Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Clinical Site
state: Pennsylvania
city: Austin
country: United States
facility: Austin Clinical Site
state: Texas
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References:
citation: Miller Ellis E, Berlin MS, Ward CL, Sharpe JA, Jamil A, Harris A. Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study. Br J Ophthalmol. 2017 Jun;101(6):796-800. doi: 10.1136/bjophthalmol-2016-309023. Epub 2016 Sep 20.