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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
Sponsored by
Kubota Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Experimental

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

First Posted
July 27, 2011
Last Updated
February 7, 2014
Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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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
No
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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