Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
This study has been completed.
Sponsor:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01670266
First received: August 15, 2012
Last updated: May 31, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Hypertension (OHT) Mild Open Angle-glaucoma (OAG) |
Drug: ONO-9054 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Ono Pharmaceutical Co. Ltd:
Primary Outcome Measures:
- Safety and tolerability of ONO-9054 [ Time Frame: up to 14 days ] [ Designated as safety issue: Yes ]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 Outcome Measures:
- Characterization of PK profiles [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]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 [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]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 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 60 |
| Study Start Date: | August 2012 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental Arm 1
Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18
|
Drug: ONO-9054 |
|
Experimental: Experimental Arm 2
Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18
|
Drug: ONO-9054 |
|
Experimental: Experimental Arm 3
Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18
|
Drug: ONO-9054 |
|
Experimental: Experimental Arm 4
Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo
|
Drug: ONO-9054 Drug: Placebo |
|
Placebo Comparator: Placebo Arm
Matched placebo eye drops dosed in same manner as ONO-9054
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670266
Locations
| United States, California | |
| Costa Mesa Clinical Site | |
| Costa Mesa, California, United States, 92626 | |
| Newport Beach (satellite site) | |
| Newport Beach, California, United States, 92663 | |
| Santa Ana (satellite site) | |
| Santa Ana, California, United States, 92705 | |
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
| Study Director: | Ono Pharma USA, Inc. | Ono Pharmaceutical Co. Ltd |
More Information
No publications provided
| Responsible Party: | Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ) |
| ClinicalTrials.gov Identifier: | NCT01670266 History of Changes |
| Other Study ID Numbers: | ONO-9054IOU002 |
| Study First Received: | August 15, 2012 |
| Last Updated: | May 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ono Pharmaceutical Co. Ltd:
|
ONO-9054 ocular hypertension OHT Open angle-glaucoma |
OAG Glaucoma Eye diseases |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension |
Eye Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013