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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 (Responsible Party):
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342081
First received: April 25, 2011
Last updated: May 19, 2015
Last verified: May 2015

April 25, 2011
May 19, 2015
May 2011
September 2012   (final data collection date for primary outcome measure)
Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study [ Time Frame: Week 0(Baseline) and Week 4(End of Study) ] [ Designated as safety issue: Yes ]
Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.
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Complete list of historical versions of study NCT01342081 on ClinicalTrials.gov Archive Site
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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(intraocular pressure) -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
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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%
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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
489
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September 2012   (final data collection date for primary outcome measure)

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   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01342081
01111004
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Santen Pharmaceutical Co., Ltd.
Santen Pharmaceutical Co., Ltd.
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Santen Pharmaceutical Co., Ltd.
May 2015

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