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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01410188

Enrollment

160

Registered

2011-08-05

Start date

2011-09-30

Completion date

2012-10-31

Last updated

2014-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Primary Open-angle Glaucoma

Keywords

open-angle glaucoma, glaucoma, ocular hypertension, intraocular pressure

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.

Interventions

DRUGOPA-6566

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

DRUGPlacebo

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

DRUGLatanoprost

Latanoprost (one drop once per day for 4 weeks)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026