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

August 15, 2012
May 31, 2013
August 2012
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01670266 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Ocular Hypertension (OHT)
  • Mild Open Angle-glaucoma (OAG)
  • Drug: ONO-9054
  • Drug: Placebo
  • Experimental: Experimental Arm 1
    Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18
    Intervention: Drug: ONO-9054
  • Experimental: Experimental Arm 2
    Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18
    Intervention: Drug: ONO-9054
  • Experimental: Experimental Arm 3
    Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18
    Intervention: 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
    Interventions:
    • Drug: ONO-9054
    • Drug: Placebo
  • Placebo Comparator: Placebo Arm
    Matched placebo eye drops dosed in same manner as ONO-9054
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01670266
ONO-9054IOU002
No
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
Ono Pharma USA Inc
Not Provided
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP