A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:Any
Updated:12/19/2018
Start Date:September 13, 2018
End Date:October 17, 2019
Contact:Santen Inc Clinical Operations
Email:clinicaltrials@santen.com
Phone:(415) 268-9052

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A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

This is a Phase III, randomized, double-masked, active-controlled, parallel-group,
multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at
Visit 1 (Screening) will washout of 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 baseline will be randomized to receive
double-masked treatment for 3 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who
meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

- DE-117 Ophthalmic Solution once daily and Vehicle once daily, or

- Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the
efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate
Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.


Inclusion Criteria:

• glaucoma or ocular hypertension

Exclusion Criteria:

- Females who are pregnant, nursing, or planning a pregnancy

- Any corneal abnormality or other condition interfering with or preventing reliable
tonometric measurements
We found this trial at
36
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8 Medical Park Drive
Asheville, North Carolina 28803
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Chandler, Arizona
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Colorado Springs, Colorado 80919
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Dallas, Texas 75231
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7106 Northwest 11th Place
Gainesville, Florida 32605
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Glendale, California 91204
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Havre de Grace, Maryland 21078
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Houston, TX
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Independence, Missouri 64055
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Inglewood, California 90301
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Kansas City, Missouri 64133
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Largo, Florida 33770
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Las Vegas, Nevada 89123
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League City, Texas 77573
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Memphis, Tennessee
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Memphis, Tennessee 38120
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1000 Corporate Center Drive
Morrow, Georgia 30260
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New York, New York 10003
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Newport Beach, California
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Ormond Beach, Florida 32174
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Petaluma, California 94954
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Poway, California 92064
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3192 Willow Creek Road
Prescott, Arizona 86301
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Roanoke, Virginia 24016
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Rochester, New York 14618
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Sacramento, California 95815
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Saint Joseph, Michigan 49085
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Salt Lake City, Utah 84117
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San Antonio, Texas 78240
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San Diego, California 92122
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San Francisco, California 94143
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Stuart, Florida 34994
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Virginia Beach, Virginia 23456
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Washington, Missouri
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Westminster, California 92683
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