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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00657579
First Posted: April 14, 2008
Last Update Posted: March 16, 2009
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.
Information provided by:
Santen Pharmaceutical Co., Ltd.
April 7, 2008
April 14, 2008
March 16, 2009
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Complete list of historical versions of study NCT00657579 on ClinicalTrials.gov Archive Site
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Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension
A Randomized, Double-Masked, Parallel-Group, Dose-Response Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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
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Interventional
Phase 2
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  • 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
  • Experimental: 1
    Intervention: Drug: DE-104 ophthalmic solution, low concentration
  • Experimental: 2
    Intervention: Drug: DE-104 ophthalmic solution, medium concentration
  • Experimental: 3
    Intervention: Drug: DE-104 ophthalmic solution, high concentration
  • Placebo Comparator: 4
    Intervention: Drug: DE-104 vehicle
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00657579
01040702
No
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Santen Pharmaceutical Co., Ltd.
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Santen Pharmaceutical Co., Ltd.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP