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

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Primary Open-angle Glaucoma
• Intervention / Treatment: Drug: OPA-6566; Drug: Latanoprost; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
    • Glendale, California, United States, 91205
  • Georgia
    • Roswell, Georgia, United States, 30076
  • Kentucky
    • Louisville, Kentucky, United States, 40217
  • Missouri
    • Washington, Missouri, United States, 63090
  • North Carolina
    • High Point, North Carolina, United States, 27262
  • Tennessee
    • Maryville, Tennessee, United States, 37803
  • Texas
    • Austin, Texas, United States, 78731
    • San Antonio, Texas, United States, 78240

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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 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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)

Secondary Outcome Measures

Outcome Measure	Time Frame
Composite of Pharmacokinetics	28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)
Efficacy: measurement of change in intraocular pressure from baseline.	28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28)

Collaborators and Investigators

• Sponsor: Kubota Vision Inc.
• Collaborators: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: John W Chandler, MD, Kubota Vision Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (Estimate): August 5, 2011

Study Record Updates

• Last Update Posted (Estimate): March 11, 2014
• Last Update Submitted That Met QC Criteria: February 7, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: open-angle glaucoma; ocular hypertension; intraocular pressure; glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: OPA-6566-101