DE-111 Against Timolol Ophthalmic Solution 0.5%

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342094
First received: April 24, 2011
Last updated: July 26, 2012
Last verified: July 2012

April 24, 2011
July 26, 2012
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Complete list of historical versions of study NCT01342094 on ClinicalTrials.gov Archive Site
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DE-111 Against Timolol Ophthalmic Solution 0.5%
A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP-lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

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Interventional
Phase 3
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  • Open Angle Glaucoma
  • Ocular Hypertension
  • Drug: DE-111 ophthalmic solution
  • Drug: Timolol ophthalmic solution 0.5%
  • Experimental: DE-111 ophthalmic solution
    Intervention: Drug: DE-111 ophthalmic solution
  • Active Comparator: Timolol ophthalmic solution 0.5%
    Intervention: Drug: Timolol ophthalmic solution 0.5%
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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
  • 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
Both
20 Years and older
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Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01342094
01111005
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Santen Pharmaceutical Co., Ltd.
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Santen Pharmaceutical Co., Ltd.
July 2012

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