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Safety and Efficacy Study 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.
ClinicalTrials.gov Identifier: NCT00657579
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : March 16, 2009
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.

Brief Summary:
To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

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

Study Type : Interventional  (Clinical Trial)
Official Title: A Randomized, Double-Masked, Parallel-Group, Dose-Response 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: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: DE-104 ophthalmic solution, low concentration
Experimental: 2 Drug: DE-104 ophthalmic solution, medium concentration
Experimental: 3 Drug: DE-104 ophthalmic solution, high concentration
Placebo Comparator: 4 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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00657579


Locations
Japan
Osaka, Japan
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier: NCT00657579     History of Changes
Other Study ID Numbers: 01040702
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009

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