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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm 1 | Experimental | Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18 |
|
| Experimental Arm 2 | Experimental | Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18 |
|
| Experimental Arm 3 | Experimental | Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18 |
|
| Experimental Arm 4 | Experimental | Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo |
|
| Placebo Arm | Placebo Comparator | Matched placebo eye drops dosed in same manner as ONO-9054 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-9054 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 14 days |
| Evaluation of PD measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Costa Mesa Clinical Site | Costa Mesa | California | 92626 | United States | ||
| Newport Beach (satellite site) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26453641 | Derived | Berlin MS, Rowe-Rendleman C, Ahmed I, Ross DT, Fujii A, Ouchi T, Quach C, Wood A, Ward CL. EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study. Br J Ophthalmol. 2016 Jun;100(6):843-7. doi: 10.1136/bjophthalmol-2015-307000. Epub 2015 Oct 9. |
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| Placebo |
| Drug |
|
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.
| 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. | 14 days |
| Newport Beach |
| California |
| 92663 |
| United States |
| Santa Ana (satellite site) | Santa Ana | California | 92705 | United States |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000607345 | propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoate |
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