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

Kubota Vision Inc.160 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Primary Open-angle Glaucoma Ocular Hypertension

Interventions

OPA-6566DRUG

OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)

PlaceboDRUG

Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)

LatanoprostDRUG

Latanoprost (one drop once per day for 4 weeks)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Artesia, California, United States

Unnamed facility

Glendale, California, United States

Unnamed facility

Roswell, Georgia, United States

Unnamed facility

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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