- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01468168
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
December 14, 2012 updated by: Santen Inc.
A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease
To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
183
Phase
- Phase 2
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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California
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New Port Beach, California, United States, 92663
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Colorado
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Parker, Colorado, United States, 80134
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Florida
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Largo, Florida, United States, 33773
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Georgia
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Morrow, Georgia, United States, 30260
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Roswell, Georgia, United States, 30076
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Maine
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Bangor, Maine, United States, 04401
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Missouri
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Kansas City, Missouri, United States, 64111
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Saint Louis, Missouri, United States, 63131
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Washington, Missouri, United States, 63090
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North Carolina
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High Point, North Carolina, United States, 27262
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Ohio
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Cleveland, Ohio, United States, 44115
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Utah
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Salt Lake City, Utah, United States, 84107
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Virginia
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Norfolk, Virginia, United States, 23507
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals considered for entry into the study will be of either sex and any race who have:
- a confirmed diagnosis of dry eye,
- are willing to use no ocular treatments during the study other than study medication,
- have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
- will not use contact lenses during the study,
- Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
- 18 years of age or older,
- able to understand and provide written informed consent
Exclusion Criteria:
- Subjects with any of the following are not eligible to participate in the study:
- Fluorescein corneal staining or conjunctival staining that is too severe
- Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
- Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
- Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
- Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
- Ocular(including lid)disease/abnormality that may interfere with the study
- Corneal transplant in either eye, at any time prior to enrollment in the study
- Laser refractive surgery less than one year prior to Visit 1 (Day 1)
- Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
- Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
- Known allergy or sensitivity to any of the study medication components
- Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
- A woman who is pregnant, nursing, or planning a pregnancy
- Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DE-101 Ophthalmic Suspension High Dose
|
Ophthalmic suspension; QID
|
Experimental: DE-101 Ophthalmic Suspension Low Dose
|
Ophthalmic suspension; QID
|
Placebo Comparator: DE-101 Ophthalmic Suspension Vehicle
|
Ophthalmic suspension vehicle; QID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tear volume increase from baseline
Time Frame: baseline and 6 months
|
baseline and 6 months
|
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
October 1, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
November 7, 2011
First Submitted That Met QC Criteria
November 8, 2011
First Posted (Estimate)
November 9, 2011
Study Record Updates
Last Update Posted (Estimate)
December 17, 2012
Last Update Submitted That Met QC Criteria
December 14, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-005
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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