Clinical trial 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
Official title: A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter 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
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: 417
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.

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.


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 (IOP) at Week 1
timeFrame: 08:00, 10:00 and 16:00 at Week 1
measure: Intraocular Pressure (IOP) at Week 6
timeFrame: 08:00, 10:00 and 16:00 at Week 6
measure: Intraocular Pressure (IOP) 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: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Prescott
country: United States
facility: M & M Eye Institute
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Inglewood
country: United States
facility: United Medical Research Inst
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates Inc.
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants
state: California
city: San Diego
country: United States
facility: AdvanceMed Clinical Research
state: California
city: Westminster
country: United States
facility: Michael K. Tran, MD, Inc.
state: California
city: Colorado Springs
country: United States
facility: Haas Vision Center
state: Colorado
city: Gainesville
country: United States
facility: Florida Ophthalmic Institute
state: Florida
city: Largo
country: United States
facility: St. Michaels Eye Laser Institute
state: Florida
city: Ormond Beach
country: United States
facility: International Eye Associates PA
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Saint Joseph
country: United States
facility: Great Lakes Eye Care P.C
state: Michigan
city: Independence
country: United States
facility: Discover Vision Centers
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care Ltd.
state: Missouri
city: Las Vegas
country: United States
facility: AdvanceMed Clinical Research
state: Nevada
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
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: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates HEA - Gramercy Location
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Alkek Eye Center
state: Texas
city: League City
country: United States
facility: The Eye Clinic of Texas
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Salt Lake City
country: United States
facility: Stacy R. Smith M.D. P.C.
state: Utah
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research
state: Virginia
Study officials:
References: