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

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT01410188
First received: July 27, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Primary Open-angle Glaucoma
Ocular Hypertension
 Drug: OPA-6566
Drug: Placebo
Drug: Latanoprost
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Drug Information available for: Latanoprost
U.S. FDA Resources

Further study details as provided by Acucela Inc.:

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. [ Time Frame: 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite of Pharmacokinetics [ Time Frame: 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410188

Locations
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
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: John W Chandler, MD Acucela Inc.
  More Information

No publications provided

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT01410188     History of Changes
Other Study ID Numbers: OPA-6566-101
Study First Received: July 27, 2011
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Acucela Inc.:
open-angle glaucoma
glaucoma
ocular hypertension
intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013