Double-Masked Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:January 28, 2019
End Date:June 17, 2019
Contact:Santen Inc. Clinical Operations
Email:clinicaltrials@santen.com
Phone:(415)-268-9199

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A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.

This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed
with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their
current topical IOP lowering medication(s), if any. After completing the required washout
period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility
criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up
to 6 weeks.

Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:

- DE-117 ophthalmic solution 0.002% QD (Once Daily)

- DE-117 ophthalmic solution 0.002% BID (Twice Daily)

This study will consist of a screening period of up to 35 days including a washout period of
up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.


Inclusion Criteria:

Provide signed written informed consent

- Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with
OHT.

- 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

- Qualifying Anterior chamber angle

Exclusion Criteria:

- History of ocular surgery specifically intended to lower IOP

- Subjects who cannot safely discontinue use of ocular hypotensive medications during
the wait/washout period

- 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 Screening and
throughout the study in either eye

- Females who are pregnant, nursing, or planning a pregnancy
We found this trial at
13
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Lynbrook, New York 11563
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Brooksville, Florida 34613
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Cincinnati, Ohio 45242
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Cleveland, Ohio 44115
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Cranberry Township, Pennsylvania 16066
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Danbury, Connecticut 06810
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Havre de Grace, Maryland 21078
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Jacksonville, Florida 32204
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Los Angeles, California 90013
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Los Angeles, CA
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Maryville, Tennessee 37803
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Nashville, Tennessee 37205
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9911 Kennerly Road
Saint Louis, Missouri 63128
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Saint Louis, MO
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Vineland, New Jersey 08361
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Vineland, NJ
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