DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342081
First received: April 25, 2011
Last updated: July 26, 2012
Last verified: July 2012

April 25, 2011
July 26, 2012
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01342081 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
A Double-masked Study of DE-111 Ophthalmic Solution Versus Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus 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 Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, 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.

Not Provided
Interventional
Phase 3
Not Provided
  • Open Angle Glaucoma
  • Ocular Hypertension
  • Drug: DE-111 ophthalmic solution
  • Drug: Tafluprost ophthalmic solution 0.0015%
  • Drug: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
  • Experimental: 1
    DE-111 ophthalmic solution
    Intervention: Drug: DE-111 ophthalmic solution
  • Active Comparator: 2
    Tafluprost ophthalmic solution 0.0015%
    Intervention: Drug: Tafluprost ophthalmic solution 0.0015%
  • Active Comparator: 3
    Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
    Intervention: Drug: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01342081
01111004
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
July 2012

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