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

Primary Purpose

Ocular Hypertension, Open Angle-glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ONO-9054
Latanoprost
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension focused on measuring ONO-9054, ocular hypertension (OHT), Open angle-glaucoma (OAG), Glaucoma, Eye Diseases, Mild to moderate

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Los Angeles Clinical Site
  • Mission Hills Clinical Site
  • Newport Beach Clinical Site
  • Pasadena Clinical Site
  • Petaluma Clinical Site
  • Morrow Clinical Site
  • Roswell Clinical Site
  • New York Clinical Site
  • High Point Clinical Site
  • Cranberry Township Clinical Site
  • Philadelphia Clinical Site
  • Austin Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm 1

Active Comparator Arm 2

Arm Description

ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.

Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diurnal IOP
Mean change from baseline in IOP at each measured time point
Treatment response rates
Percent change from baseline in IOP at each measured time point

Full Information

First Posted
March 6, 2014
Last Updated
January 26, 2016
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02083289
Brief Title
A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open Angle-glaucoma
Keywords
ONO-9054, ocular hypertension (OHT), Open angle-glaucoma (OAG), Glaucoma, Eye Diseases, Mild to moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm 1
Arm Type
Experimental
Arm Description
ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.
Arm Title
Active Comparator Arm 2
Arm Type
Active Comparator
Arm Description
Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.
Intervention Type
Drug
Intervention Name(s)
ONO-9054
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Other Intervention Name(s)
Xalatan®
Primary Outcome Measure Information:
Title
Mean change in diurnal IOP (average of four time points) from baseline
Time Frame
28 days
Title
Evaluating the safety parameters per protocol
Description
Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Diurnal IOP
Time Frame
28 days
Title
Mean change from baseline in IOP at each measured time point
Time Frame
28 days
Title
Treatment response rates
Time Frame
28 days
Title
Percent change from baseline in IOP at each measured time point
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharmaceutical Co., Ltd.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Los Angeles Clinical Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mission Hills Clinical Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Newport Beach Clinical Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pasadena Clinical Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Petaluma Clinical Site
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Morrow Clinical Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Roswell Clinical Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
New York Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
High Point Clinical Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Cranberry Township Clinical Site
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Philadelphia Clinical Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Austin Clinical Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27649982
Citation
Miller Ellis E, Berlin MS, Ward CL, Sharpe JA, Jamil A, Harris A. Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study. Br J Ophthalmol. 2017 Jun;101(6):796-800. doi: 10.1136/bjophthalmol-2016-309023. Epub 2016 Sep 20.
Results Reference
derived

Learn more about this trial

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

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