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 3 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:June 18, 2020
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, Multi-center 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 3 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. Adult subjects will receive open-label DE-117
Ophthalmic Solution for an additional 9 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 and will
provide additional safety data through Month 12 for subjects receiving DE-117.


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
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Brooksville, Florida 34613
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Burbank, California 91506
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Charleston, South Carolina 29414
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Charlotte, North Carolina 28210
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Colorado Springs, Colorado 80910
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Cranberry Township, Pennsylvania 16066
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2516 Sheridan Road Southeast
Falls Church, Virginia 22046
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Fort Myers, Florida 33901
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Fort Worth, Texas 76102
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High Point, North Carolina 27262
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7205 Bonneval Road
Jacksonville, Florida 32256
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Kansas City, Missouri 64111
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Las Vegas, Nevada 89119
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Mount Pleasant, South Carolina 29464
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Wantagh, New York 11793
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