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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01670266
First received: August 15, 2012
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Ocular Hypertension (OHT)
Mild Open Angle-glaucoma (OAG)
Drug: ONO-9054
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Safety and tolerability of ONO-9054 [ Time Frame: up to 14 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 60
Study Start Date: August 2012
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm 1
Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18
Drug: ONO-9054
Experimental: Experimental Arm 2
Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18
Drug: ONO-9054
Experimental: Experimental Arm 3
Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18
Drug: ONO-9054
Experimental: Experimental Arm 4
Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo
Drug: ONO-9054 Drug: Placebo
Placebo Comparator: Placebo Arm
Matched placebo eye drops dosed in same manner as ONO-9054
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670266

Locations
United States, California
Costa Mesa Clinical Site
Costa Mesa, California, United States, 92626
Newport Beach (satellite site)
Newport Beach, California, United States, 92663
Santa Ana (satellite site)
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01670266     History of Changes
Other Study ID Numbers: ONO-9054IOU002
Study First Received: August 15, 2012
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-9054
ocular hypertension
OHT
Open angle-glaucoma
OAG
Glaucoma
Eye diseases

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014