Mild Open Angle-glaucoma (OAG), Ocular Hypertension (OHT)
Conditions
Keywords
ONO-9054, ocular hypertension, OHT, Open angle-glaucoma, OAG, Glaucoma, Eye diseases
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.
Interventions
DRUGONO-9054
DRUGPlacebo
Sponsors
Ono Pharma USA Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of ONO-9054 | 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
| Measure | Time frame | Description |
|---|---|---|
| Characterization of PK profiles | 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 |
| Evaluation of PD measurements | 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. |
| Comparison of safety, tolerability between once daily morning and once daily evening | 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. |
Countries
United States
Outcome results
None listed