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

Use our guide to learn which trials are right for you!

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
We found this trial at
36
sites
Bloomington, Indiana 47405
?
mi
from
Bloomington, IN
Click here to add this to my saved trials
Albany, Georgia 31701
?
mi
from
Albany, GA
Click here to add this to my saved trials
Alpharetta, Georgia 30076
?
mi
from
Alpharetta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bellevue, Washington 98004
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Brooksville, Florida 34613
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Burbank, California 91506
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Charleston, South Carolina 29414
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cranberry Township, Pennsylvania 16066
?
mi
from
Cranberry Township, PA
Click here to add this to my saved trials
2516 Sheridan Road Southeast
Falls Church, Virginia 22046
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Fort Myers, Florida 33901
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fort Worth, Texas 76102
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
High Point, North Carolina 27262
?
mi
from
High Point, NC
Click here to add this to my saved trials
7205 Bonneval Road
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Largo, Florida
?
mi
from
Largo, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89119
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Maryville, Tennessee 37803
?
mi
from
Maryville, TN
Click here to add this to my saved trials
?
mi
from
Mission, TX
Click here to add this to my saved trials
Mission Hills, California
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
721 Long Point Road
Mount Pleasant, South Carolina 29464
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
Phoenix, Arizona 85050
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Rancho Cordova, California 95670
?
mi
from
Rancho Cordova, CA
Click here to add this to my saved trials
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78230
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Barbara, California 93110
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Shawnee Mission, Kansas 66204
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
South Orange, New Jersey 07079
?
mi
from
South Orange, NJ
Click here to add this to my saved trials
Sun City, Arizona 85351
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Wantagh, New York 11793
?
mi
from
Wantagh, NY
Click here to add this to my saved trials