NCT01410188

Brief Summary

This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

9 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

July 27, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 11, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

July 27, 2011

Last Update Submit

February 7, 2014

Conditions

Primary Open-angle GlaucomaOcular Hypertension

Keywords

open-angle glaucomaglaucomaocular hypertensionintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine.

    28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)

Secondary Outcomes (2)

  • Composite of Pharmacokinetics

    28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)

  • Efficacy: measurement of change in intraocular pressure from baseline.

    28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28)

Study Arms (6)

OPA-6566 low dose

EXPERIMENTAL

Treatment with OPA-6566 low dose

Drug: OPA-6566

OPA-6566 medium dose

EXPERIMENTAL

Treatment with OPA-6566 medium dose

Drug: OPA-6566

OPA-6566 high dose

EXPERIMENTAL

Treatment with OPA-6566 high dose

Drug: OPA-6566

Latanoprost

ACTIVE COMPARATOR

Treatment with Latanoprost

Drug: Latanoprost

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

OPA-6566 additional dose

EXPERIMENTAL

Treatment with OPA-6566 additional dose

Drug: OPA-6566

Interventions

OPA-6566DRUG

OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)

OPA-6566 additional doseOPA-6566 high doseOPA-6566 low doseOPA-6566 medium dose
PlaceboDRUG

Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)

Placebo
LatanoprostDRUG

Latanoprost (one drop once per day for 4 weeks)

Latanoprost

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of bilateral primary open-angle glaucoma
  • diagnosis of ocular hypertension as defined in the protocol

You may not qualify if:

  • any form of glaucoma other than primary open-angle glaucoma in either eye
  • other ocular conditions as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Artesia, California, 90701, United States

Location

Unknown Facility

Glendale, California, 91205, United States

Location

Unknown Facility

Roswell, Georgia, 30076, United States

Location

Unknown Facility

Louisville, Kentucky, 40217, United States

Location

Unknown Facility

Washington, Missouri, 63090, United States

Location

Unknown Facility

High Point, North Carolina, 27262, United States

Location

Unknown Facility

Maryville, Tennessee, 37803, United States

Location

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • John W Chandler, MD

    Kubota Vision Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2011

First Posted

August 5, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 11, 2014

Record last verified: 2014-02

Locations

US(9)