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

Primary Purpose

Primary Open-angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OPA-6566

Placebo

Latanoprost

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring open-angle glaucoma, glaucoma, ocular hypertension, intraocular pressure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Arm Label

OPA-6566 low dose

OPA-6566 medium dose

OPA-6566 high dose

Latanoprost

Placebo

OPA-6566 additional dose

Arm Description

Treatment with OPA-6566 low dose

Treatment with OPA-6566 medium dose

Treatment with OPA-6566 high dose

Treatment with Latanoprost

Placebo

Treatment with OPA-6566 additional dose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Composite of Pharmacokinetics

Efficacy: measurement of change in intraocular pressure from baseline.

Full Information

NCT ID

NCT01410188

First Posted

July 27, 2011

Last Updated

February 7, 2014

Sponsor

Kubota Vision Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01410188

Brief Title

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

Official Title

An Investigator-Masked, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kubota Vision Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open-angle Glaucoma, Ocular Hypertension

Keywords

open-angle glaucoma, glaucoma, ocular hypertension, intraocular pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OPA-6566 low dose

Arm Type

Experimental

Arm Description

Treatment with OPA-6566 low dose

Arm Title

OPA-6566 medium dose

Arm Type

Experimental

Arm Description

Treatment with OPA-6566 medium dose

Arm Title

OPA-6566 high dose

Arm Type

Experimental

Arm Description

Treatment with OPA-6566 high dose

Arm Title

Latanoprost

Arm Type

Active Comparator

Arm Description

Treatment with Latanoprost

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

OPA-6566 additional dose

Arm Type

Experimental

Arm Description

Treatment with OPA-6566 additional dose

Intervention Type

Drug

Intervention Name(s)

OPA-6566

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Latanoprost

Intervention Description

Latanoprost (one drop once per day for 4 weeks)

Primary Outcome Measure Information:

Title

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Composite of Pharmacokinetics

Time Frame

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

Title

Efficacy: measurement of change in intraocular pressure from baseline.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John W Chandler, MD

Organizational Affiliation

Kubota Vision Inc.

Official's Role

Study Director

Facility Information:

City

Artesia

State/Province

California

ZIP/Postal Code

90701

Country

United States

City

Glendale

State/Province

California

ZIP/Postal Code

91205

Country

United States

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

City

Washington

State/Province

Missouri

ZIP/Postal Code

63090

Country

United States

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

City

Maryville

State/Province

Tennessee

ZIP/Postal Code

37803

Country

United States

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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