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

PHASE3CompletedINTERVENTIONAL
Enrollment

417

Participants

Timeline

Start Date

September 27, 2018

Primary Completion Date

October 23, 2019

Study Completion Date

October 23, 2019

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

DRUG

Timolol Maleate Ophthalmic Solution 0.5%

Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

Trial Locations (34)

14618

Rochester Ophthalmological Group, PC, Rochester

21078

Seidenberg Protzko Eye Associates, Havre de Grace

23456

Tidewater Clinical Research, Virginia Beach

30260

Clayton Eye Clinical Research, LLC, Morrow

32174

International Eye Associates PA, Ormond Beach

34994

East Florida Eye Institute, Stuart

38120

VRF Eye Specialty Group, Memphis

44115

Abrams Eye Center, Cleveland

49085

Great Lakes Eye Care P.C, Saint Joseph

64133

Silverstein Eye Centers, Kansas City

77030

Baylor College of Medicine Alkek Eye Center, Houston

84117

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

85224

Arizona Eye Center, Chandler

89123

AdvanceMed Clinical Research, Las Vegas

90301

United Medical Research Inst, Inglewood

91204

Global Research Management, Glendale

92122

AdvanceMed Clinical Research, San Diego

86301-6610

M & M Eye Institute, Prescott

92663-3642

Eye Research Foundation, Newport Beach

94954-2387

North Bay Eye Associates Inc., Petaluma

95815-4605

Sacramento Eye Consultants, Sacramento

92683-7071

Michael K. Tran, MD, Inc., Westminster

80919-5913

Haas Vision Center, Colorado Springs

32605-3192

Florida Ophthalmic Institute, Gainesville

33770-3225

St. Michaels Eye Laser Institute, Largo

64055-6974

Discover Vision Centers, Independence

63090-3010

Comprehensive Eye Care Ltd., Washington

28803-2493

Asheville Eye Associates, Asheville

38119-5770

Total Eye Care PA, Memphis

75231-2168

Glaucoma Associates of Texas, Dallas

77025-1756

Houston Eye Associates HEA - Gramercy Location, Houston

77573-5148

The Eye Clinic of Texas, League City

78240-1502

Medical Center Ophthalmology Associates, San Antonio

24016-5100

Vistar Eye Center, Roanoke

All Listed Sponsors
lead

Santen Inc.

INDUSTRY

NCT03691662 - 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 | Biotech Hunter | Biotech Hunter