To Investigate the Safety and Efficacy of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00656240

Last Updated: 2009-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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To investigate the intraocular pressure (IOP)-lowering effect and safety of DE-104 ophthalmic solution in patients with Primary Open-Angle Glaucoma or Ocular Hypertension

Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Groups

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1

Group Type EXPERIMENTAL

DE-104 ophthalmic solution

Intervention Type DRUG

2

Group Type EXPERIMENTAL

DE-104 vehicle

Intervention Type DRUG

Interventions

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DE-104 ophthalmic solution

Intervention Type DRUG

DE-104 vehicle

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.
* 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

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Locations

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Osaka, Japan

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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01040703

Identifier Type: -

Identifier Source: org_study_id

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