NCT02083289

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

February 25, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

March 6, 2014

Last Update Submit

January 26, 2016

Conditions

Ocular HypertensionOpen Angle-glaucoma

Keywords

ONO-9054ocular hypertension (OHT)Open angle-glaucoma (OAG)GlaucomaEye DiseasesMild to moderate

Outcome Measures

Primary Outcomes (2)

  • Mean change in diurnal IOP (average of four time points) from baseline

    28 days

  • 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

    28 days

Secondary Outcomes (4)

  • Diurnal IOP

    28 days

  • Mean change from baseline in IOP at each measured time point

    28 days

  • Treatment response rates

    28 days

  • Percent change from baseline in IOP at each measured time point

    28 days

Study Arms (2)

Experimental Arm 1

EXPERIMENTAL

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

Drug: ONO-9054

Active Comparator Arm 2

ACTIVE COMPARATOR

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

Drug: Latanoprost

Interventions

ONO-9054DRUG
Experimental Arm 1
LatanoprostDRUG
Also known as: Xalatan®
Active Comparator Arm 2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Los Angeles Clinical Site

Los Angeles, California, 90048, United States

Location

Mission Hills Clinical Site

Mission Hills, California, 91345, United States

Location

Newport Beach Clinical Site

Newport Beach, California, 92663, United States

Location

Pasadena Clinical Site

Pasadena, California, 91105, United States

Location

Petaluma Clinical Site

Petaluma, California, 94954, United States

Location

Morrow Clinical Site

Morrow, Georgia, 30260, United States

Location

Roswell Clinical Site

Roswell, Georgia, 30076, United States

Location

New York Clinical Site

New York, New York, 10029, United States

Location

High Point Clinical Site

High Point, North Carolina, 27262, United States

Location

Cranberry Township Clinical Site

Cranberry Township, Pennsylvania, 16066, United States

Location

Philadelphia Clinical Site

Philadelphia, Pennsylvania, 19104, United States

Location

Austin Clinical Site

Austin, Texas, 78731, United States

Location

Related Publications (1)

  • 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.

    PMID: 27649982DERIVED

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-AngleGlaucomaEye Diseases

Interventions

propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoateLatanoprost

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Ono Pharmaceutical Co., Ltd.

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 11, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Last Updated

February 25, 2016

Record last verified: 2016-01

Locations

US(12)