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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental Arm 1

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

Group Type EXPERIMENTAL

ONO-9054

Intervention Type DRUG

Experimental Arm 2

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

Group Type EXPERIMENTAL

ONO-9054

Intervention Type DRUG

Experimental Arm 3

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

Group Type EXPERIMENTAL

ONO-9054

Intervention Type DRUG

Experimental Arm 4

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

Group Type EXPERIMENTAL

ONO-9054

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo Arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ONO-9054

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No