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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: October 2012

Interventions

  • Drug: OPA-6566
    • OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
  • Drug: Placebo
    • Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
  • Drug: Latanoprost
    • Latanoprost (one drop once per day for 4 weeks)

Arms, Groups and Cohorts

  • Experimental: OPA-6566 low dose
    • Treatment with OPA-6566 low dose
  • Experimental: OPA-6566 medium dose
    • Treatment with OPA-6566 medium dose
  • Experimental: OPA-6566 high dose
    • Treatment with OPA-6566 high dose
  • Active Comparator: Latanoprost
    • Treatment with Latanoprost
  • Placebo Comparator: Placebo
    • Placebo
  • Experimental: OPA-6566 additional dose
    • Treatment with OPA-6566 additional dose

Clinical Trial Outcome Measures

Primary 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)

Secondary Measures

  • Composite of Pharmacokinetics
    • Time Frame: 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kubota Vision Inc.
  • Collaborator
    • Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John W Chandler, MD, Study Director, Kubota Vision Inc.

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