DE-117 Spectrum 5 Study



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:September 27, 2018
End Date:November 30, 2019
Contact:Santen Inc Clinical Operations
Email:clinicaltrials@santen.com
Phone:415-268-9052

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An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117
ophthalmic solution 0.002% in latanoprost/non-responder subjects diagnosed with POAG or OHT


Inclusion Criteria:

- Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.

- Provide signed written informed consent.

- Diagnosis of POAG or OHT in both eyes.

- Qualifying corrected visual acuity in each eye.

- Qualifying central corneal thickness in each eye.

- Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost
Run-in Period.

- Qualifying Anterior chamber angle.

Exclusion Criteria:

- Patients who cannot safely discontinue use of Ocular Hypotensive Medications during
Washout.

- Patients with prior exposure to DE-117.

- History of ocular surgery specifically intended to lower IOP

- Advanced glaucoma in either eye.

- Any corneal abnormality or other condition interfering with or preventing reliable
Goldmann applanation tonometry.

- Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1
(Screening) and throughout the study in either eye.

- Females who are pregnant, nursing, or planning a pregnancy.
We found this trial at
28
sites
1000 Corporate Center Drive
Morrow, Georgia 30260
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Albany, Georgia 31701
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Albany, GA
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8 Medical Park Drive
Asheville, North Carolina 28803
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Asheville, NC
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Austin, Texas 78731
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Austin, TX
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Chandler, Arizona
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Chandler, AZ
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Charlotte, North Carolina
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Charlotte, NC
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Cleveland, Ohio 44115
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Cleveland, OH
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Danbury, Connecticut 06810
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Danbury, CT
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Glendale, California 91204
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Glendale, CA
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High Point, North Carolina 27262
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High Point, NC
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Largo, Florida
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Largo, FL
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League City, Texas 77573
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League City, TX
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Memphis, Tennessee
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Memphis, TN
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Mission Hills, California
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Mission Hills, CA
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721 Long Point Road
Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Nashville, Tennessee 37205
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Nashville, TN
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Newport Beach, California
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Newport Beach, CA
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Ormond Beach, Florida 32174
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Ormond Beach, FL
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Petaluma, California 94954
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Petaluma, CA
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Rancho Cordova, California 95670
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Rancho Cordova, CA
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Rochester, New York 14618
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Rochester, NY
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Roswell, Georgia 30076
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Roswell, GA
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9911 Kennerly Road
Saint Louis, Missouri 63128
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Saint Louis, MO
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San Antonio, Texas 78240
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San Antonio, TX
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Shawnee Mission, Kansas 66204
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Shawnee Mission, KS
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Tulsa, Oklahoma 74104
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Tulsa, OK
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Wantagh, New York 14618
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Wantagh, NY
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Washington, Missouri
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Washington, MO
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