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

This study has been completed.

Sponsor:

Information provided by:

Santen Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01343082

First received: April 24, 2011

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	April 24, 2011
Last Updated Date	February 6, 2013
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01343082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Official Title ^ICMJE	A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-
Brief Summary	Safety and IOP lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Open Angle Glaucoma or Ocular Hypertension
Intervention ^ICMJE	Drug: DE-111 ophthalmic solution
Study Arm (s)	Experimental: 1 DE-111 ophthalmic solution Intervention: Drug: DE-111 ophthalmic solution
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01343082
Other Study ID Numbers ^ICMJE	01111006
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Santen Pharmaceutical Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Santen Pharmaceutical Co., Ltd.
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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