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

COMPLETEDPHASE1

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

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

NCT01670266•Ono Pharma USA Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

August 1, 2012

Primary Completion Date

May 1, 2013

Last Updated

June 3, 2013

Enrollment

ACTUAL participants

Conditions

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

Interventions

ONO-9054

DRUG

Placebo

DRUG

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

NCT02226094

Primary Open-angle Glaucoma (POAG)Ocular Hypertension (OHT)

View study

COMPLETEDPHASE2

AL-54478 Proof of Concept Study

NCT01318252

Open-angle Glaucoma (OAG)Ocular Hypertension (OHT)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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