A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)

January 26, 2016 updated by: Ono Pharmaceutical Co. Ltd

A 28-day Double-masked, Randomized, Parallel-group, Active Controlled Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)

The primary objectives of this study are to compare the safety, tolerability, and mean change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to latanoprost 0.005% following ocular instillation once every evening for 28 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Los Angeles Clinical Site
      • Mission Hills, California, United States, 91345
        • Mission Hills Clinical Site
      • Newport Beach, California, United States, 92663
        • Newport Beach Clinical Site
      • Pasadena, California, United States, 91105
        • Pasadena Clinical Site
      • Petaluma, California, United States, 94954
        • Petaluma Clinical Site
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Morrow Clinical Site
      • Roswell, Georgia, United States, 30076
        • Roswell Clinical Site
    • New York
      • New York, New York, United States, 10029
        • New York Clinical Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • High Point Clinical Site
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Cranberry Township Clinical Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia Clinical Site
    • Texas
      • Austin, Texas, United States, 78731
        • Austin Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female aged 18-85 (inclusive) with confirmed diagnosis of OHT or OAG
  • Confirmed diagnosis of bilateral OHT or mild to moderate chronic OAG
  • Able to undergo washout of all ocular drugs
  • An IOP ≥ 24 mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least 1 eye; but < 36 mmHg in both eyes at both Day -5 and Day 1
  • Central corneal thickness 500-620 µm at screening and Day -5 in both eyes
  • Best corrected visual acuity (BCVA) of +0.7 Log Mar or better

Exclusion Criteria:

  • Any history of severe ocular trauma in either eye at any time
  • History of angle closure 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 or photography of the fundus in either eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm 1
ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.
Drug: ONO-9054
Active Comparator: Active Comparator Arm 2
Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.
Drug: Latanoprost
Other Names:
  • Xalatan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in diurnal IOP (average of four time points) from baseline
Time Frame: 28 days
28 days
Evaluating the safety parameters per protocol
Time Frame: 28 days
Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Diurnal IOP
Time Frame: 28 days
28 days
Mean change from baseline in IOP at each measured time point
Time Frame: 28 days
28 days
Treatment response rates
Time Frame: 28 days
28 days
Percent change from baseline in IOP at each measured time point
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-9054IOU003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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