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

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

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
sites
Chandler, Arizona
358
mi
from 91732
Chandler, AZ
Click here to add this to my saved trials
8 Medical Park Drive
Asheville, North Carolina 28803
2004
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
Colorado Springs, Colorado 80919
?
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Dallas, Texas 75231
1226
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
7106 Northwest 11th Place
Gainesville, Florida 32605
2100
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
Glendale, California 91204
14
mi
from 91732
Glendale, CA
Click here to add this to my saved trials
Havre de Grace, Maryland 21078
?
mi
from 91732
Havre de Grace, MD
Click here to add this to my saved trials
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Independence, Missouri 64055
1350
mi
from 91732
Independence, MO
Click here to add this to my saved trials
Inglewood, California 90301
?
mi
from 91732
Inglewood, CA
Click here to add this to my saved trials
Kansas City, Missouri 64133
1347
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
Largo, Florida 33770
?
mi
from 91732
Largo, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89123
217
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
League City, Texas 77573
1379
mi
from 91732
League City, TX
Click here to add this to my saved trials
Memphis, Tennessee
1586
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
Memphis, Tennessee 38120
1593
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
1000 Corporate Center Drive
Morrow, Georgia 30260
1924
mi
from 91732
Morrow, GA
Click here to add this to my saved trials
New York, New York 10003
2351
mi
from 91732
New York, NY
Click here to add this to my saved trials
Newport Beach, California
31
mi
from 91732
Newport Beach, CA
Click here to add this to my saved trials
Ormond Beach, Florida 32174
2186
mi
from 91732
Ormond Beach, FL
Click here to add this to my saved trials
Petaluma, California 94954
385
mi
from 91732
Petaluma, CA
Click here to add this to my saved trials
Poway, California 92064
?
mi
from 91732
Poway, CA
Click here to add this to my saved trials
3192 Willow Creek Road
Prescott, Arizona 86301
319
mi
from 91732
Prescott, AZ
Click here to add this to my saved trials
Roanoke, Virginia 24016
2133
mi
from 91732
Roanoke, VA
Click here to add this to my saved trials
Rochester, New York 14618
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
Sacramento, California 95815
365
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
Saint Joseph, Michigan 49085
1790
mi
from 91732
Saint Joseph, MI
Click here to add this to my saved trials
Salt Lake City, Utah 84117
?
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78240
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92122
106
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94143
356
mi
from 91732
San Francisco, CA
Click here to add this to my saved trials
Stuart, Florida 34994
2280
mi
from 91732
Stuart, FL
Click here to add this to my saved trials
Virginia Beach, Virginia 23456
2350
mi
from 91732
Virginia Beach, VA
Click here to add this to my saved trials
Washington, Missouri
1529
mi
from 91732
Washington, MO
Click here to add this to my saved trials
Westminster, California 92683
22
mi
from 91732
Westminster, CA
Click here to add this to my saved trials