Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT01410188

Last Updated: 2014-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Open-angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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OPA-6566 low dose

Treatment with OPA-6566 low dose

Group Type EXPERIMENTAL

OPA-6566

Intervention Type DRUG

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

OPA-6566 medium dose

Treatment with OPA-6566 medium dose

Group Type EXPERIMENTAL

OPA-6566

Intervention Type DRUG

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

OPA-6566 high dose

Treatment with OPA-6566 high dose

Group Type EXPERIMENTAL

OPA-6566

Intervention Type DRUG

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

Latanoprost

Treatment with Latanoprost

Group Type ACTIVE_COMPARATOR

Latanoprost

Intervention Type DRUG

Latanoprost (one drop once per day for 4 weeks)

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

OPA-6566 additional dose

Treatment with OPA-6566 additional dose

Group Type EXPERIMENTAL

OPA-6566

Intervention Type DRUG

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

Interventions

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OPA-6566

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Latanoprost

Latanoprost (one drop once per day for 4 weeks)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kubota Vision Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John W Chandler, MD

Role: STUDY_DIRECTOR

Kubota Vision Inc.

Locations

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Artesia, California, United States

Site Status

Glendale, California, United States

Site Status

Roswell, Georgia, United States

Site Status

Louisville, Kentucky, United States

Site Status

Washington, Missouri, United States

Site Status

High Point, North Carolina, United States

Site Status

Maryville, Tennessee, United States

Site Status

Austin, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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OPA-6566-101

Identifier Type: -

Identifier Source: org_study_id

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