DE-111 Against Timolol Ophthalmic Solution 0.5%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342094
First received: April 24, 2011
Last updated: June 14, 2015
Last verified: June 2015

April 24, 2011
June 14, 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 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(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: Timolol ophthalmic solution 0.5%
  • Drug: Placebo ophthalmic solution
  • Experimental: DE-111 ophthalmic solution
    DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
    Interventions:
    • Drug: DE-111 ophthalmic solution
    • Drug: Placebo ophthalmic solution
  • Active Comparator: Timolol ophthalmic solution 0.5%
    Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
    Interventions:
    • Drug: Timolol ophthalmic solution 0.5%
    • Drug: Placebo 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
166
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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
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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.
Santen Pharmaceutical Co., Ltd.
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Santen Pharmaceutical Co., Ltd.
June 2015

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