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DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343082
First Posted: April 27, 2011
Last Update Posted: June 15, 2015
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 (Responsible Party):
Santen Pharmaceutical Co., Ltd.
April 24, 2011
April 27, 2011
April 28, 2015
May 14, 2015
June 15, 2015
May 2011
March 2013   (Final data collection date for primary outcome measure)
Change From Baseline in IOP (Intraocular Pressure) at End of Study [ Time Frame: Treatment period: Week 0 (Baseline) and Week 52 (End of Study) ]
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Complete list of historical versions of study NCT01343082 on ClinicalTrials.gov Archive Site
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DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-
Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.
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Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Open Angle Glaucoma or Ocular Hypertension
Drug: DE-111 ophthalmic solution
Experimental: 1
DE-111 ophthalmic solution
Intervention: Drug: DE-111 ophthalmic solution
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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
148
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March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with open angle glaucoma or ocular hypertension
  • Provided signed, written informed consent
  • 20 years of age and older
  • 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 and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01343082
01111006
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Santen Pharmaceutical Co., Ltd.
Santen Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
May 2015

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