Back to resultsMulticenter 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 (ANGEL-2)
Primary Purpose
Primary Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DE-126 Ophthalmic Solution 0.002% QD
Timolol Maleate Ophthalmic Solution 0.5% BID
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Glaucoma
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
Sites / Locations
- Arizona Eye Center
- Arizona Glaucoma Specialists
- Walman Eye Center
- Global Research Management
- Premiere Practice Management
- North Valley Eye Medical Group
- The Eye Research Foundation
- University of California, Los Angeles, Doheny Eye Centers
- North Bay Eye Associates, Inc
- Sacramento Eye Consultants
- University of Colorado, Dept. of Opthamology
- Hernando Eye Institute
- Eye Associates of Fort Myers
- Levenson Eye Associates
- Mayo Clinic, Dept. of Opthamology
- Bowden Eye & Associates
- Shettle Eye Research
- Dixophthal PC dba Dixon Eye Care
- Clayton Eye Clinical Research, LLC
- Coastal Research Associates
- Clinical Eye Research of Boston, LLC
- Nevada Eye Care Professionals
- AdvanceMed Clinical Research-Las Vegas
- Northern New Jersey Eye Institute
- Rochester Ophthalmological Group, P.C.
- Duke Eye Center
- Wake Forest Health Network Ophthamology - Oak Hollow
- Vance Thompson Vision - ND
- Apex Eye Clinical Research, LLC
- Office of Mark J. Weiss MD
- Scott & Christie and Associates PC
- Wills Eye Hospital
- Black Hills Regional Eye Institute
- University Eye Specialists
- VRF Eye Specialty Group
- Glaucoma Associates of Texas
- The Cataract and Glaucoma Center
- DCT- Shah Research LLC dba Discovery Clinical Trials
- San Antonio Eye Center
- R and R Eye Research LLC
- Stacy R. Smith M.D. P.C.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
Timolol Maleate Opthalmic Solution 0.5% BID
Arm Description
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Outcomes
Primary Outcome Measures
Intraocular Pressure at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Intraocular Pressure at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Intraocular Pressure at Month 3
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Secondary Outcome Measures
Mean Diurnal Intraocular Pressure at Month 3
Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04742283
Brief Title
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
Acronym
ANGEL-2
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
Arm Type
Experimental
Arm Description
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
Arm Title
Timolol Maleate Opthalmic Solution 0.5% BID
Arm Type
Active Comparator
Arm Description
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
DE-126 Ophthalmic Solution 0.002% QD
Intervention Description
DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate Ophthalmic Solution 0.5% BID
Intervention Description
Timolol Maleate Ophthalmic Solution BID (morning and evening)
Primary Outcome Measure Information:
Title
Intraocular Pressure at Week 2
Description
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Time Frame
08:00, 10:00 and 16:00 at Week 2
Title
Intraocular Pressure at Week 6
Description
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Time Frame
08:00, 10:00 and 16:00 at Week 6
Title
Intraocular Pressure at Month 3
Description
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Time Frame
08:00, 10:00 and 16:00 at Month 3
Secondary Outcome Measure Information:
Title
Mean Diurnal Intraocular Pressure at Month 3
Description
Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject.
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Glaucoma Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Walman Eye Center
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351-3019
Country
United States
Facility Name
Global Research Management
City
Glendale
State/Province
California
ZIP/Postal Code
91204-2569
Country
United States
Facility Name
Premiere Practice Management
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
The Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3642
Country
United States
Facility Name
University of California, Los Angeles, Doheny Eye Centers
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
North Bay Eye Associates, Inc
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Sacramento Eye Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95815-4605
Country
United States
Facility Name
University of Colorado, Dept. of Opthamology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613-6065
Country
United States
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-9311
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Mayo Clinic, Dept. of Opthamology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Bowden Eye & Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Shettle Eye Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Dixophthal PC dba Dixon Eye Care
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701-2363
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Coastal Research Associates
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Clinical Eye Research of Boston, LLC
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Nevada Eye Care Professionals
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
AdvanceMed Clinical Research-Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123-2810
Country
United States
Facility Name
Northern New Jersey Eye Institute
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079-1855
Country
United States
Facility Name
Rochester Ophthalmological Group, P.C.
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Wake Forest Health Network Ophthamology - Oak Hollow
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262-7612
Country
United States
Facility Name
Vance Thompson Vision - ND
City
W. Fargo
State/Province
North Dakota
ZIP/Postal Code
58078
Country
United States
Facility Name
Apex Eye Clinical Research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Office of Mark J. Weiss MD
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104-5300
Country
United States
Facility Name
Scott & Christie and Associates PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066-6412
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701-7374
Country
United States
Facility Name
University Eye Specialists
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803-6100
Country
United States
Facility Name
VRF Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120-9411
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-2168
Country
United States
Facility Name
The Cataract and Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
DCT- Shah Research LLC dba Discovery Clinical Trials
City
Mission
State/Province
Texas
ZIP/Postal Code
78572-2425
Country
United States
Facility Name
San Antonio Eye Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215-1936
Country
United States
Facility Name
R and R Eye Research LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3539
Country
United States
Facility Name
Stacy R. Smith M.D. P.C.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117-5209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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