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

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00657579
First received: April 7, 2008
Last updated: March 12, 2009
Last verified: March 2009

April 7, 2008
March 12, 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.
Both
20 Years to 74 Years
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