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

This study is ongoing, but not recruiting participants.

Sponsored by:	Santen Pharmaceutical Co., Ltd.
Information provided by:	Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00656240

Purpose

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

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: DE-104 ophthalmic solution Drug: DE-104 vehicle	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

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

Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Arms	Assigned Interventions
1: Experimental	Drug: DE-104 ophthalmic solution
2: Experimental	Drug: DE-104 vehicle

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656240

Locations

Japan
Osaka, Japan
Osaka, Japan

Sponsors and Collaborators

Santen Pharmaceutical Co., Ltd.

More Information

Study ID Numbers:	01040703
Study First Received:	April 7, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00656240
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle

Vascular Diseases
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009