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

PHASE3CompletedINTERVENTIONAL
Enrollment

426

Participants

Timeline

Start Date

September 14, 2018

Primary Completion Date

December 6, 2019

Study Completion Date

September 3, 2020

Conditions
Glaucoma and Ocular Hypertension
Interventions
DRUG

DE-117 Ophthalmic Solution

Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

DRUG

Timolol Maleate Ophthalmic Solution 0.5%

Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Trial Locations (47)

10003

NY Eye & ear Infirmary of Mt Sinai (NYEE), New York

11793

South Shore Eye Care, LLP, Wantagh

16066

Scott & Christie and Associates PC, Cranberry Township

22046

Emerson Clinical Research Institute, Falls Church

27262

Cornerstone Eye Care, High Point

28210

Charlotte Eye Ear Nose & Throat Associates, PA, Charlotte

30076

Coastal Research Associates, Alpharetta

30260

Clayton Eye Clinical Research, LLC, Morrow

32256

Bowden Eye & Associates, Jacksonville

33773

Shettle Eye Research, Largo

37803

University Eye Specialists, Maryville

43215

Ophthalmic Surgeons & Consultants of Ohio, Inc., Columbus

45242

Apex Eye Clinical Research, LLC, Cincinnati

47405

Indiana University, Bloomington

57701

Black Hills Regional Eye Institute, LLP, Rapid City

64111

Tauber Eye Center, Kansas City

76102

Ophthalmology Associates, Fort Worth

78229

R and R Eye Research LLC, San Antonio

79902

The Cataract and Glaucoma Center, El Paso

80909

MCB Clinical Research Centers LLC, Colorado Springs

85050

Arizona Glaucoma Specialists, Phoenix

89119

Nevada Eye Care Professionals, Las Vegas

Wellish Vision Institute, Las Vegas

91345

North Valley Eye Medical Group, Mission Hills

91506

Havana Research Institute, Burbank

93110

Samsum Clinic (DocTrials), Santa Barbara

94954

North Bay Eye Associates, Inc, Petaluma

95670

Martel Eye Medical Group, Rancho Cordova

98004

Specialty Eye Care Centre, Bellevue

662204

Heart of America Eye Care, P.A., Shawnee Mission

85351-3019

DocTrials Walman Eye Center, Sun City

90048-6149

Macy Eye Center, Los Angeles

34613-6065

Hernando Eye Institute, Brooksville

33901-9311

Eye Associates of Fort Myers, Fort Myers

31701-2363

Dixophthal PC Dba. Dixon Eye Care, Albany

01890

Clinical Eye Research of Boston, LLC, Winchester

89123-2810

AdvanceMed Clinical Research-Las Vegas, Las Vegas

07079-1855

Northern New Jersey Eye Institute, South Orange

28803-2493

Asheville Eye Associates, Asheville

74104-5300

Office of Mark J. Weiss MD, Tulsa

29464-8298

Glaucoma Consultants and Center for Eye Research PA, Mt. Pleasant

38119-5770

Total Eye Care PA, Memphis

78731-4203

Keystone Research Ltd. Texan Eye PA, Austin

78572-2425

Shah Research LLC dba Discovery Clinical Trials, Mission

78215-1936

San Antonio Eye Center, San Antonio

78230-5141

Delay Winter Eye Consultants LLC, San Antonio

84117-5209

Stacy R. Smith M.D. P.C., Salt Lake City

All Listed Sponsors
lead

Santen Inc.

INDUSTRY

NCT03691649 - 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 | Biotech Hunter | Biotech Hunter