Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Otsuka

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: OPC-1085EL ophthalmic solution; Drug: Carteolol long-acting ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02105285

1085EL-13-003

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.

Enrollment: 193 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Exclusion criteria

• Subjects with ocular conditions as defined by the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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193 participants in 2 patient groups

OPC-1085EL ophthalmic solution

Experimental group

Description:

Once daily

Treatment:

Drug: OPC-1085EL ophthalmic solution

Carteolol long-acting ophthalmic solution

Active Comparator group

Description:

Once daily

Treatment:

Drug: Carteolol long-acting ophthalmic solution