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

Ono Pharma USA Inc60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Costa Mesa Clinical Site

Costa Mesa, California, United States

Newport Beach (satellite site)

Newport Beach, California, United States

Santa Ana (satellite site)

Santa Ana, California, United States

Outcomes

Primary Outcomes

Safety and tolerability of ONO-9054

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

Time frame: up to 14 days

Secondary Outcomes

Characterization of PK profiles

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

Time frame: up to 14 days

Evaluation of PD measurements

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.

Time frame: up to 14 days

Comparison of safety, tolerability between once daily morning and once daily evening

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.

Time frame: 14 days