NCT01670266

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

9 months

First QC Date

August 15, 2012

Last Update Submit

May 31, 2013

Conditions

Ocular Hypertension (OHT)Mild Open Angle-glaucoma (OAG)

Keywords

ONO-9054ocular hypertensionOHTOpen angle-glaucomaOAGGlaucomaEye diseases

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of ONO-9054

    Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days

    up to 14 days

Secondary Outcomes (3)

  • Characterization of PK profiles

    up to 14 days

  • Evaluation of PD measurements

    up to 14 days

  • Comparison of safety, tolerability between once daily morning and once daily evening

    14 days

Study Arms (5)

Experimental Arm 1

EXPERIMENTAL

Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18

Drug: ONO-9054

Experimental Arm 2

EXPERIMENTAL

Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18

Drug: ONO-9054

Experimental Arm 3

EXPERIMENTAL

Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18

Drug: ONO-9054

Experimental Arm 4

EXPERIMENTAL

Experimental Eye drop, 2 sequence crossover Cohort \[1 dose; 1-30 µg/mL\]to be determined and placebo

Drug: ONO-9054Drug: Placebo

Placebo Arm

PLACEBO COMPARATOR

Matched placebo eye drops dosed in same manner as ONO-9054

Drug: Placebo

Interventions

ONO-9054DRUG
Experimental Arm 1Experimental Arm 2Experimental Arm 3Experimental Arm 4
PlaceboDRUG
Experimental Arm 4Placebo Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Costa Mesa Clinical Site

Costa Mesa, California, 92626, United States

Location

Newport Beach (satellite site)

Newport Beach, California, 92663, United States

Location

Santa Ana (satellite site)

Santa Ana, California, 92705, United States

Location

Related Publications (1)

  • 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.

    PMID: 26453641DERIVED

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-AngleGlaucomaEye Diseases

Interventions

propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoate

Study Officials

  • Ono Pharma USA, Inc.

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 22, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2013

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

US(3)