- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01343082
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
May 19, 2015 updated by: Santen Pharmaceutical Co., Ltd.
A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka, Japan
- Santen study sites
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
DE-111 ophthalmic solution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in IOP (Intraocular Pressure) at End of Study
Time Frame: Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
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Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
April 24, 2011
First Submitted That Met QC Criteria
April 26, 2011
First Posted (Estimate)
April 27, 2011
Study Record Updates
Last Update Posted (Estimate)
June 15, 2015
Last Update Submitted That Met QC Criteria
May 19, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01111006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Open Angle Glaucoma or Ocular Hypertension
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Santen Pharmaceutical Co., Ltd.CompletedOpen Angle Glaucoma or Ocular HypertensionSingapore
-
Santen Pharmaceutical Co., Ltd.CompletedOpen Angle Glaucoma or Ocular HypertensionJapan
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Santen SASActive, not recruitingOcular Surface Disease | Open-Angle Glaucoma or Ocular HypertensionFrance
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Otsuka Beijing Research InstituteRecruitingOpen Angle Glaucoma or Ocular HypertensionChina
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Santen Inc.CompletedOpen-angle Glaucoma or Ocular HypertensionUnited States
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Aerie PharmaceuticalsCompletedPrimary Open Angle Glaucoma or Ocular HypertensionUnited States
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Aerie PharmaceuticalsCompletedPrimary Open Angle Glaucoma or Ocular HypertensionUnited States
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Santen Pharmaceutical Co., Ltd.CompletedPrimary Open Angle Glaucoma or Ocular HypertensionJapan
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Maisonneuve-Rosemont HospitalRecruitingPatients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)Canada
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Ocular Therapeutix, Inc.CompletedOpen Angle Glaucoma and Ocular HypertensionUnited States
Clinical Trials on DE-111 ophthalmic solution
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Qlaris Bio, Inc.Not yet recruitingGlaucoma | Normal Tension Glaucoma (NTG) | Low-Tension Glaucoma, Bilateral | Low-Tension Glaucoma, Unspecified EyeKorea, Republic of, Philippines
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Santen Inc.CompletedOcular Hypertension | Open-angle GlaucomaUnited States
-
Santen Pharmaceutical Co., Ltd.Completed
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Santen Pharmaceutical Co., Ltd.CompletedOcular Hypertension | Open-Angle GlaucomaJapan
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Santen Inc.CompletedOpen-angle Glaucoma, Ocular HypertensionUnited States, Japan
-
Santen Pharmaceutical Co., Ltd.CompletedPrimary Open Angle Glaucoma | Ocular HypertensionJapan
-
Qlaris Bio, Inc.RecruitingPrimary Open Angle Glaucoma of Both Eyes | Primary Open Angle Glaucoma (POAG) | Primary Open-Angle Glaucoma, Unspecified Eye | Ocular Hypertension (OHT)United States
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Santen Inc.CompletedPrimary Open-angle Glaucoma and Ocular HypertensionUnited States
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Qlaris Bio, Inc.RecruitingGlaucoma | Open-angle Glaucoma (OAG) | Ocular Hypertension (OHT)United States
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Santen Inc.CompletedOcular Hypertension | Open-Angle GlaucomaUnited States