Back to resultsDE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open Angle Glaucoma or Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
DE-111 ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma or Ocular Hypertension
Eligibility 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.
Sites / Locations
- Santen study sites
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
DE-111 ophthalmic solution
Outcomes
Primary Outcome Measures
Change From Baseline in IOP (Intraocular Pressure) at End of Study
Secondary Outcome Measures
Full Information
NCT ID
NCT01343082
First Posted
April 24, 2011
Last Updated
May 19, 2015
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01343082
Brief Title
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma or Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
DE-111 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
DE-111 ophthalmic solution
Primary Outcome Measure Information:
Title
Change From Baseline in IOP (Intraocular Pressure) at End of Study
Time Frame
Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility 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.
Facility Information:
Facility Name
Santen study sites
City
Osaka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
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