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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Investigator)
- Study Primary Completion Date: October 2012
- 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
- Experimental: OPA-6566 additional dose
- Treatment with OPA-6566 additional dose
Clinical Trial 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)
- 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
- 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
- Lead Sponsor
- Kubota Vision Inc.
- Otsuka Pharmaceutical Co., Ltd.
- Provider of Information About this Clinical Study
- Overall Official(s)
- John W Chandler, MD, Study Director, Kubota Vision Inc.
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