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Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ONO-9054
Placebo
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension (OHT) focused on measuring ONO-9054, ocular hypertension, OHT, Open angle-glaucoma, OAG, Glaucoma, Eye diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Costa Mesa Clinical Site
  • Newport Beach (satellite site)
  • Santa Ana (satellite site)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental Arm 1

Experimental Arm 2

Experimental Arm 3

Experimental Arm 4

Placebo Arm

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Characterization of PK profiles
The mean concentrations of ONO-9054 and its active metabolite will be measured in plasma in order to determine peak and trough levels over a dosing period of 14 days
Evaluation of PD measurements
The pharmacodynamic measurement will be intraocular pressure. Relative changes with respect to baseline will be assessed after 14 days of administration under both AM and PM dosing conditions.
Comparison of safety, tolerability between once daily morning and once daily evening
Safety and tolerability of a single concentration will be evaluated by review of adverse events and any change from baseline in ocular symptoms in a crossover arm in which the active drug is administered for 14 days under both AM and PM dosing conditions.

Full Information

First Posted
August 15, 2012
Last Updated
May 31, 2013
Sponsor
Ono Pharma USA Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01670266
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension (OHT), Mild Open Angle-glaucoma (OAG)
Keywords
ONO-9054, ocular hypertension, OHT, Open angle-glaucoma, OAG, Glaucoma, Eye diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm 1
Arm Type
Experimental
Arm Description
Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18
Arm Title
Experimental Arm 2
Arm Type
Experimental
Arm Description
Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18
Arm Title
Experimental Arm 3
Arm Type
Experimental
Arm Description
Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18
Arm Title
Experimental Arm 4
Arm Type
Experimental
Arm Description
Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Matched placebo eye drops dosed in same manner as ONO-9054
Intervention Type
Drug
Intervention Name(s)
ONO-9054
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability of ONO-9054
Description
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
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
Characterization of PK profiles
Description
The mean concentrations of ONO-9054 and its active metabolite will be measured in plasma in order to determine peak and trough levels over a dosing period of 14 days
Time Frame
up to 14 days
Title
Evaluation of PD measurements
Description
The pharmacodynamic measurement will be intraocular pressure. Relative changes with respect to baseline will be assessed after 14 days of administration under both AM and PM dosing conditions.
Time Frame
up to 14 days
Title
Comparison of safety, tolerability between once daily morning and once daily evening
Description
Safety and tolerability of a single concentration will be evaluated by review of adverse events and any change from baseline in ocular symptoms in a crossover arm in which the active drug is administered for 14 days under both AM and PM dosing conditions.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharma USA, Inc.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Costa Mesa Clinical Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Newport Beach (satellite site)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Santa Ana (satellite site)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26453641
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.
Results Reference
derived

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Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma

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