DE-111 Against Timolol Ophthalmic Solution 0.5%

NCT ID: NCT01342094

Last Updated: 2015-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Brief Summary

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DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

Detailed Description

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Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DE-111 ophthalmic solution

DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.

Group Type EXPERIMENTAL

DE-111 ophthalmic solution

Intervention Type DRUG

Placebo ophthalmic solution

Intervention Type DRUG

Timolol ophthalmic solution 0.5%

Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.

Group Type ACTIVE_COMPARATOR

Timolol ophthalmic solution 0.5%

Intervention Type DRUG

Placebo ophthalmic solution

Intervention Type DRUG

Interventions

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DE-111 ophthalmic solution

Intervention Type DRUG

Timolol ophthalmic solution 0.5%

Intervention Type DRUG

Placebo ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with primary open angle glaucoma or ocular hypertension
* Provided signed, written informed consent
* 20 years of age and older
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study

Exclusion Criteria

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
* Presence of any abnormality or significant illness that could be expected to interfere with the study
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Santen study sites

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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01111005

Identifier Type: -

Identifier Source: org_study_id

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