Clinical trial NCT03697811: DE-117 Spectrum 5 Study
Official title: An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-05
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
timeFrame: Month 3
Secondary outcomes:
measure: Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
timeFrame: week 2, 6 and month 3
measure: Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
timeFrame: week 2 and 6
measure: Change From Baseline in IOP at Timepoints at Week 2
timeFrame: 08:00, 12:00 and 16:00 at Week 2
measure: Change From Baseline in IOP at Timepoints at Week 6
timeFrame: 08:00, 12:00 and 16:00 at Week 6
measure: Change From Baseline in IOP at Timepoints at Month 3
timeFrame: 08:00, 12:00 and 16:00 at month 3
measure: Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
timeFrame: 08:00, 12:00 and 16:00 at week 2
measure: Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
timeFrame: 08:00, 12:00 and 16:00 at week 6
measure: Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
timeFrame: 08:00, 12:00 and 16:00 at month 3.
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Danbury
country: United States
facility: Danbury Eye Physicians & Surgeons
state: Connecticut
city: Largo
country: United States
facility: Shettle Eye Research, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: International Eye Associates, PA
state: Florida
city: Albany
country: United States
facility: Dixon Eye Care
state: Georgia
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates, LEC
state: Georgia
city: Shawnee Mission
country: United States
facility: Heart of America Eye Care, P.A.
state: Kansas
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care Ltd
state: Missouri
city: New York
country: United States
facility: NYU Langone Health Department of Ophthalmology
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Center
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates, PLLC
state: North Carolina
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Health Care
state: North Carolina
city: Cincinnati
country: United States
facility: Apex Eye Clinical Research, LLC
state: Ohio
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Tulsa
country: United States
facility: The Eye Institute
state: Oklahoma
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates PC
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Glaucoma Consultants and Center for Eye Research, PA
state: South Carolina
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
city: Memphis
country: United States
facility: VRF Eye Specialty Group
state: Tennessee
city: Nashville
country: United States
facility: Nashville Vision Associates
state: Tennessee
city: Austin
country: United States
facility: Texas Eye, PA
state: Texas
city: League City
country: United States
facility: Eye Clinic of Texas
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
References: