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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656240
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : March 16, 2009
Information provided by:
Santen Pharmaceutical Co., Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: DE-104 ophthalmic solution Drug: DE-104 vehicle Phase 2

Study Type : Interventional  (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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: DE-104 ophthalmic solution
Experimental: 2 Drug: DE-104 vehicle

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656240

Osaka, Japan
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd. Identifier: NCT00656240     History of Changes
Other Study ID Numbers: 01040703
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions