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

Phase 1

Completed

• Conditions: Primary Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Latanoprost; Drug: OPA-6566; Drug: Placebo

• Registration Number: NCT01410188
• Lead Sponsor: Kubota Vision Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-05
• Study Start: 2011-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-02
• Disposition First Submitted: 2014-02-07
• Disposition First Submitted QC: 2014-02-07
• Last Update Submitted: 2014-02-07
• Disposition First Posted: 2014-03-11
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Latanoprost	Latanoprost	Treatment with Latanoprost
OPA-6566 low dose	OPA-6566	Treatment with OPA-6566 low dose
Placebo	Placebo	Placebo
OPA-6566 additional dose	OPA-6566	Treatment with OPA-6566 additional dose
OPA-6566 medium dose	OPA-6566	Treatment with OPA-6566 medium dose
OPA-6566 high dose	OPA-6566	Treatment with OPA-6566 high dose

Primary Outcome Measures

Name	Time	Method
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.	28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)

Secondary Outcome Measures

Name	Time	Method
Composite of Pharmacokinetics	28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)
Efficacy: measurement of change in intraocular pressure from baseline.	28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28)