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

Sponsor

Kubota Vision Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01410188

Collaborator

Otsuka Pharmaceutical Co., Ltd. (Industry)

160

Enrollment

Locations

Arms

Duration (Months)

17.8

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma Ocular Hypertension	Drug: OPA-6566 Drug: Placebo Drug: Latanoprost	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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 Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPA-6566 low dose Treatment with OPA-6566 low dose	Drug: OPA-6566 OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Experimental: OPA-6566 medium dose Treatment with OPA-6566 medium dose	Drug: OPA-6566 OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Experimental: OPA-6566 high dose Treatment with OPA-6566 high dose	Drug: OPA-6566 OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Active Comparator: Latanoprost Treatment with Latanoprost	Drug: Latanoprost Latanoprost (one drop once per day for 4 weeks)
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Experimental: OPA-6566 additional dose Treatment with OPA-6566 additional dose	Drug: OPA-6566 OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)

Outcome Measures

Primary 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. [28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Artesia	California	United States	90701
2	Glendale	California	United States	91205
3	Roswell	Georgia	United States	30076
4	Louisville	Kentucky	United States	40217
5	Washington	Missouri	United States	63090
6	High Point	North Carolina	United States	27262
7	Maryville	Tennessee	United States	37803
8	Austin	Texas	United States	78731
9	San Antonio	Texas	United States	78240