Clinical trial 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
Official title: A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multi-center 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma and Ocular Hypertension
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 426
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

* DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
* Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will provide additional safety data through Month 12 for subjects receiving DE-117.


Eligibility criteria: Inclusion Criteria:

• glaucoma or ocular hypertension

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy
* Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

Primary outcomes:
measure: Intraocular Pressure at Week 1
timeFrame: 08:00, 10:00 and 16:00 at Week 1
measure: Intraocular Pressure at Week 6
timeFrame: 08:00, 10:00 and 16:00 at Week 6
measure: Intraocular Pressure at Month 3
timeFrame: 08:00, 10:00 and 16:00 at Month 3
Secondary outcomes:
measure: Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)
timeFrame: Month 3
measure: Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
timeFrame: 08:00, 10:00 and 16:00 at Week 1
measure: Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
timeFrame: 08:00, 10:00 and 16:00 at Week 6
measure: Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
timeFrame: 08:00, 10:00 and 16:00 at Month 3
measure: Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)
timeFrame: Week 1
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Glaucoma Specialists
state: Arizona
city: Sun City
country: United States
facility: DocTrials Walman Eye Center
state: Arizona
city: Burbank
country: United States
facility: Havana Research Institute
state: California
city: Los Angeles
country: United States
facility: Macy Eye Center
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Santa Barbara
country: United States
facility: Samsum Clinic (DocTrials)
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers LLC
state: Colorado
city: Brooksville
country: United States
facility: Hernando Eye Institute
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Jacksonville
country: United States
facility: Bowden Eye & Associates
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Albany
country: United States
facility: Dixophthal PC Dba. Dixon Eye Care
state: Georgia
city: Alpharetta
country: United States
facility: Coastal Research Associates
state: Georgia
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Shawnee Mission
country: United States
facility: Heart of America Eye Care, P.A.
state: Kansas
city: Winchester
country: United States
facility: Clinical Eye Research of Boston, LLC
state: Massachusetts
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Eye Care Professionals
state: Nevada
city: Las Vegas
country: United States
facility: Wellish Vision Institute
state: Nevada
city: Las Vegas
country: United States
facility: AdvanceMed Clinical Research-Las Vegas
state: Nevada
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute
state: New Jersey
city: New York
country: United States
facility: NY Eye & ear Infirmary of Mt Sinai (NYEE)
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care, LLP
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, PA
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Cincinnati
country: United States
facility: Apex Eye Clinical Research, LLC
state: Ohio
city: Columbus
country: United States
facility: Ophthalmic Surgeons & Consultants of Ohio, Inc.
state: Ohio
city: Tulsa
country: United States
facility: Office of Mark J. Weiss MD
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: Rapid City
country: United States
facility: Black Hills Regional Eye Institute, LLP
state: South Dakota
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
city: Austin
country: United States
facility: Keystone Research Ltd. Texan Eye PA
state: Texas
city: El Paso
country: United States
facility: The Cataract and Glaucoma Center
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: Mission
country: United States
facility: Shah Research LLC dba Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research LLC
state: Texas
city: San Antonio
country: United States
facility: Delay Winter Eye Consultants LLC
state: Texas
city: Salt Lake City
country: United States
facility: Stacy R. Smith M.D. P.C.
state: Utah
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
city: Bellevue
country: United States
facility: Specialty Eye Care Centre
state: Washington
Study officials:
References: