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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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ClinicalTrials.gov Identifier: NCT01670266
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : June 3, 2013
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2012
Primary Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability of ONO-9054 [ Time Frame: up to 14 days ]
    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 :
  1. Characterization of PK profiles [ Time Frame: up to 14 days ]
    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

  2. Evaluation of PD measurements [ Time Frame: up to 14 days ]
    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.

  3. Comparison of safety, tolerability between once daily morning and once daily evening [ Time Frame: 14 days ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670266

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
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT01670266     History of Changes
Other Study ID Numbers: ONO-9054IOU002
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
ocular hypertension
Open angle-glaucoma
Eye diseases

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