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

NCT ID: NCT02105285

Last Updated: 2015-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OPC-1085EL ophthalmic solution

Once daily

Group Type EXPERIMENTAL

OPC-1085EL ophthalmic solution

Intervention Type DRUG

Carteolol long-acting ophthalmic solution

Once daily

Group Type ACTIVE_COMPARATOR

Carteolol long-acting ophthalmic solution

Intervention Type DRUG

Interventions

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OPC-1085EL ophthalmic solution

Intervention Type DRUG

Carteolol long-acting ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kansai Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1085EL-13-003

Identifier Type: -

Identifier Source: org_study_id