- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342081
DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
May 19, 2015 updated by: Santen Pharmaceutical Co., Ltd.
A Double-masked Study of DE-111 Ophthalmic Solution Versus Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus 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 Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
489
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 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.
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
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
DE-111 ophthalmic solution
|
|
Active Comparator: 2
Tafluprost ophthalmic solution 0.0015%
|
|
Active Comparator: 3
Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study
Time Frame: Week 0(Baseline) and Week 4(End of Study)
|
Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.
|
Week 0(Baseline) and Week 4(End of Study)
|
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)
September 1, 2012
Study Registration Dates
First Submitted
April 25, 2011
First Submitted That Met QC Criteria
April 25, 2011
First Posted (Estimate)
April 26, 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
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Timolol
- Ophthalmic Solutions
- Pharmaceutical Solutions
Other Study ID Numbers
- 01111004
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.
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