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

NCT01410188 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2014-03-11

No results posted yet for this study

Summary

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.

Conditions

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)

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Kubota Vision Inc.

    lead INDUSTRY

Principal Investigators

  • John W Chandler, MD · Kubota Vision Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410188 on ClinicalTrials.gov