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OpenTrials
Completed

NCT Number: NCT01670266

Single and Multiple Dose Escalation and Two-sequence Crossover Study 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Costa Mesa Clinical Site, Costa Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-9054

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
First posted
Aug 22, 2012
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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