A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
NCT ID: NCT01468168
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2011-10-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DE-101 Ophthalmic Suspension High Dose
DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
DE-101 Ophthalmic Suspension Low Dose
DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
DE-101 Ophthalmic Suspension Vehicle
DE-101 Ophthalmic Suspension Vehicle
Ophthalmic suspension vehicle; QID
Interventions
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DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
DE-101 Ophthalmic Suspension
Ophthalmic suspension; QID
DE-101 Ophthalmic Suspension Vehicle
Ophthalmic suspension vehicle; QID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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New Port Beach, California, United States
Parker, Colorado, United States
Largo, Florida, United States
Morrow, Georgia, United States
Roswell, Georgia, United States
Bangor, Maine, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Washington, Missouri, United States
High Point, North Carolina, United States
Cleveland, Ohio, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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26-005
Identifier Type: -
Identifier Source: org_study_id