A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

PHASE2CompletedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

July 25, 2017

Primary Completion Date

February 27, 2018

Study Completion Date

February 27, 2018

Conditions
Open-angle Glaucoma, Ocular Hypertension
Interventions
DRUG

Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution

Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks

DRUG

Topical ultra-low dose of DE-126 Ophthalmic Solution

Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

DRUG

Topical low dose of DE-126 Ophthalmic Solution

Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

DRUG

Topical medium dose of DE-126 Ophthalmic Solution

Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

DRUG

Topical high dose of DE-126 Ophthalmic Solution

Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks

DRUG

0.005% Latanoprost Ophthalmic Solution

0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks

Trial Locations (17)

14618

Rochester Ophthalmological Group, PC, Rochester

27262

Cornerstone Health Care, LLC, High Point

28204

Mundorf Eye Center, Charlotte

30076

Coastal Research Associates, LLC, Roswell

30260

Clayton Eye Clinical Research, LLC, Morrow

33773

Shettle Eye Research, Inc., Largo

78240

Keystone Research LTD SMO/Medical Center Ophthalmology Assoc., San Antonio

78731

Keystone Research Ltd SMO/Texan Eye, PA, Austin

90701

Sall Research Medical Center, Inc, Artesia

91345

North Valley Eye Medical Group, Mission Hills

92657

Eye Research Foundation, INC, Newport Beach

94954

North Bay Eye Associates, Inc., Petaluma

Unknown

Murakami Karindoh Hospital, Fukuoka-shi, Fukuoka

Nagasaka Eye Clinic, Nagoya-shi, Aichi

Sugiura Eye Clinic, Osaka-shi, Osaka

Sapporo Katoh Ophthalmology Clinic, Sapporo-shi, Hokkaido

Dogenzaka Kato Eye Clinic, Shibuya-ku, Tokyo

All Listed Sponsors
lead

Santen Inc.

INDUSTRY

NCT03216902 - A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study | Biotech Hunter | Biotech Hunter