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

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.
 
ClinicalTrials.gov Identifier: NCT01343082
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : May 14, 2015
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma or Ocular Hypertension Drug: DE-111 ophthalmic solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-
Study Start Date : May 2011
Actual Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
DE-111 ophthalmic solution
 Drug: DE-111 ophthalmic solution


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in IOP (Intraocular Pressure) at End of Study [ Time Frame: Treatment period: Week 0 (Baseline) and Week 52 (End of Study) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343082


Locations
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Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01343082    
Other Study ID Numbers: 01111006
First Posted: April 27, 2011    Key Record Dates
Results First Posted: May 14, 2015
Last Update Posted: June 15, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions