DE-117 Spectrum 5 Study

Completed · Phase 3

Conditions studied: Primary Open-angle Glaucoma and Ocular Hypertension

In brief

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Key facts

Study ID

NCT03697811

Run by

Santen Inc.

People needed

107

Starts

2018-09-27

Expected to finish

2022-01-13

Last updated by the study team

2023-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
• Provide signed written informed consent.
• Diagnosis of POAG or OHT in both eyes.
• Qualifying corrected visual acuity in each eye.
• Qualifying central corneal thickness in each eye.
• Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period.
• Qualifying Anterior chamber angle.
• Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

You may not qualify if…

• Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
• Patients with prior exposure to DE-117.
• History of ocular surgery specifically intended to lower IOP
• Advanced glaucoma in either eye.
• Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.
• Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
• Females who are pregnant, nursing, or planning a pregnancy.

Where it is running

• Arizona Eye Center — Chandler, Arizona, United States
• Global Research Management — Glendale, California, United States
• North Valley Eye Medical Group — Mission Hills, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• North Bay Eye Associates — Petaluma, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Danbury Eye Physicians & Surgeons — Danbury, Connecticut, United States
• Shettle Eye Research, Inc. — Largo, Florida, United States
• International Eye Associates, PA — Ormond Beach, Florida, United States
• Dixon Eye Care — Albany, Georgia, United States
• Clayton Eye Clinical Research, LLC — Morrow, Georgia, United States
• Coastal Research Associates, LEC — Roswell, Georgia, United States
• Heart of America Eye Care, P.A. — Shawnee Mission, Kansas, United States
• Tekwani Vision Center — St Louis, Missouri, United States
• Comprehensive Eye Care Ltd — Washington, Missouri, United States
• NYU Langone Health Department of Ophthalmology — New York, New York, United States
• Rochester Ophthalmological Group, PC — Rochester, New York, United States
• South Shore Eye Center — Wantagh, New York, United States
• Asheville Eye Associates, PLLC — Asheville, North Carolina, United States
• Mundorf Eye Center — Charlotte, North Carolina, United States
• Cornerstone Health Care — High Point, North Carolina, United States
• Apex Eye Clinical Research, LLC — Cincinnati, Ohio, United States
• Abrams Eye Center — Cleveland, Ohio, United States
• The Eye Institute — Tulsa, Oklahoma, United States
• Scott & Christie and Associates PC — Cranberry Township, Pennsylvania, United States

Full record on ClinicalTrials.gov

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