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NCT00656240 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official title:
A Randomized, Double-Masked, Parallel-Group Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00656240
Other study ID # 01040703
Secondary ID
Status Completed
Phase Phase 2
First received April 7, 2008
Last updated March 12, 2009

Study information
Verified date March 2009
Source Santen Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• DE-104 ophthalmic solution

• DE-104 vehicle

Locations
Country Name City State
Japan Osaka, Japan Osaka

Sponsors (1)
Lead Sponsor Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

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