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

Ocular Hypertension (OHT) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670266
• Other study ID #: ONO-9054IOU002
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2012
• Last updated: May 31, 2013
• Start date: August 2012

Study information

• Verified date: May 2013
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Mild Open Angle-glaucoma (OAG)
• Ocular Hypertension
• Ocular Hypertension (OHT)

Intervention

Drug:
• ONO-9054

• Placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharma USA Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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.	up to 14 days	No
Secondary	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	Yes