We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01410188
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : March 11, 2014
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Kubota Vision Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Ocular Hypertension Drug: OPA-6566 Drug: Placebo Drug: Latanoprost Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : September 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: OPA-6566 low dose
Treatment with OPA-6566 low dose
 Drug: OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Experimental: OPA-6566 medium dose
Treatment with OPA-6566 medium dose
 Drug: OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Experimental: OPA-6566 high dose
Treatment with OPA-6566 high dose
 Drug: OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Active Comparator: Latanoprost
Treatment with Latanoprost
 Drug: Latanoprost
Latanoprost (one drop once per day for 4 weeks)
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Experimental: OPA-6566 additional dose
Treatment with OPA-6566 additional dose
 Drug: OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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. [ 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 Measures :
  1. Composite of Pharmacokinetics [ Time Frame: 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28) ]
  2. 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) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410188


Locations
Layout table for location information
United States, California
Artesia, California, United States, 90701
Glendale, California, United States, 91205
United States, Georgia
Roswell, Georgia, United States, 30076
United States, Kentucky
Louisville, Kentucky, United States, 40217
United States, Missouri
Washington, Missouri, United States, 63090
United States, North Carolina
High Point, North Carolina, United States, 27262
United States, Tennessee
Maryville, Tennessee, United States, 37803
United States, Texas
Austin, Texas, United States, 78731
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Kubota Vision Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Study Director: John W Chandler, MD Kubota Vision Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kubota Vision Inc.
ClinicalTrials.gov Identifier: NCT01410188    
Other Study ID Numbers: OPA-6566-101
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: February 2014
Keywords provided by Kubota Vision Inc.:
open-angle glaucoma
glaucoma
ocular hypertension
intraocular pressure
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions