NCT01410188

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Kubota Vision Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Primary Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-08-05
• Last updated: 2014-03-11

Locations

9 sites across 1 country: United States