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

Kubota Vision

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ocular Hypertension; Primary Open-angle Glaucoma

Treatments: Drug: Placebo; Drug: Latanoprost; Drug: OPA-6566

Study type: Interventional

Funder types: Industry

Identifiers

NCT01410188

OPA-6566-101

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

160 participants in 6 patient groups, including a placebo group

OPA-6566 low dose

Experimental group

Description:

Treatment with OPA-6566 low dose

Treatment:

Drug: OPA-6566

OPA-6566 medium dose

Experimental group

Description:

Treatment with OPA-6566 medium dose

Treatment:

Drug: OPA-6566

OPA-6566 high dose

Experimental group

Description:

Treatment with OPA-6566 high dose

Treatment:

Drug: OPA-6566

Latanoprost

Active Comparator group

Description:

Treatment with Latanoprost

Treatment:

Drug: Latanoprost

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

OPA-6566 additional dose

Experimental group

Description:

Treatment with OPA-6566 additional dose

Treatment:

Drug: OPA-6566