Clinical trial NCT04742283: Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Official title: A Phase IIb, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.

This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

The IOP will be measured at 3 different times throughout the day, over 4 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, and vital signs. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
* Completed the required wait/washout period
* Qualifying Day 1 IOP measurement at 3 time-points in both eyes

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy
* Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
* History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
* Presence of advanced glaucoma in either eye

Primary outcomes:
measure: Intraocular Pressure at Week 2
timeFrame: 08:00, 10:00 and 16:00 at Week 2
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 at Month 3
timeFrame: Three months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Glaucoma Specialists
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Los Angeles
country: United States
facility: Premiere Practice Management
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation
state: California
city: Pasadena
country: United States
facility: University of California, Los Angeles, Doheny Eye Centers
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: Aurora
country: United States
facility: University of Colorado, Dept. of Opthamology
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: Levenson Eye Associates
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic, Dept. of Opthamology
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: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates
state: Georgia
city: Winchester
country: United States
facility: Clinical Eye Research of Boston, LLC
state: Massachusetts
city: Las Vegas
country: United States
facility: Nevada Eye Care Professionals
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: Rochester
country: United States
facility: Rochester Ophthalmological Group, P.C.
state: New York
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: High Point
country: United States
facility: Wake Forest Health Network Ophthamology - Oak Hollow
state: North Carolina
city: W. Fargo
country: United States
facility: Vance Thompson Vision - ND
state: North Dakota
city: Cincinnati
country: United States
facility: Apex Eye Clinical Research, LLC
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: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Maryville
country: United States
facility: University Eye Specialists
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: El Paso
country: United States
facility: The Cataract and Glaucoma Center
state: Texas
city: Mission
country: United States
facility: DCT- 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: Salt Lake City
country: United States
facility: Stacy R. Smith M.D. P.C.
state: Utah
Study officials:
References: