Clinical trial NCT01670266: Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
Official title: A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ocular Hypertension (OHT)
Mild Open Angle-glaucoma (OAG)
Keywords: ONO-9054
ocular hypertension
OHT
Open angle-glaucoma
OAG
Glaucoma
Eye diseases
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG).

The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its tolerability following morning and evening dosing.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG
* Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma
* Able to undergo washout of all ocular drugs
* An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; but ≤ 35 mmHg at all time points in both eyes on Day -2 and Day -1
* Central corneal thickness 500-600 µm at screening in both eyes
* BCVA 20/100 or better in both eyes

Exclusion Criteria:

* Any history of severe ocular trauma in either eye at any time
* Any history of previous intraocular 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 of the fundus in either eye

Primary outcomes:
measure: Safety and tolerability of ONO-9054
timeFrame: up to 14 days
Secondary outcomes:
measure: Characterization of PK profiles
timeFrame: up to 14 days
measure: Evaluation of PD measurements
timeFrame: up to 14 days
measure: Comparison of safety, tolerability between once daily morning and once daily evening
timeFrame: 14 days
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Costa Mesa Clinical Site
state: California
city: Newport Beach
country: United States
facility: Newport Beach (satellite site)
state: California
city: Santa Ana
country: United States
facility: Santa Ana (satellite site)
state: California
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
citation: Berlin MS, Rowe-Rendleman C, Ahmed I, Ross DT, Fujii A, Ouchi T, Quach C, Wood A, Ward CL. EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study. Br J Ophthalmol. 2016 Jun;100(6):843-7. doi: 10.1136/bjophthalmol-2015-307000. Epub 2015 Oct 9.