A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
1 other identifier
interventional
241
2 countries
17
Brief Summary
Treatment 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 four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 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, vital signs, and clinical laboratory tests. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2017
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedStudy Start
First participant enrolled
July 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2018
CompletedResults Posted
Study results publicly available
October 23, 2020
CompletedOctober 23, 2020
September 1, 2020
7 months
July 11, 2017
August 21, 2020
September 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular Pressure in the Study Eye at Month 3
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
9:00, 13:00 and 17:00 at Month 3
Secondary Outcomes (9)
Intraocular Pressure in the Study Eye at Week 6
9:00, 13:00 and 17:00 at Week 6
Intraocular Pressure in the Study Eye at Week 1 and Week 2
9:00, 13:00 and 17:00 at Week 1 and Week 2
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 1, Week 2, Week 6 and Month 3.
- +4 more secondary outcomes
Study Arms (6)
Placebo (Vehicle of DE-126) followed by high dose of DE-126
PLACEBO COMPARATORUltra-low dose 0.0005% DE-126
EXPERIMENTALLow dose 0.001% DE-126
EXPERIMENTALMedium dose 0.002% DE-126
EXPERIMENTALHigh dose 0.003% DE-126
EXPERIMENTAL0.005% Latanoprost
ACTIVE COMPARATORInterventions
Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
- Qualifying Anterior chamber angle
You may not qualify if:
- History of ocular surgery specifically intended to lower IOP
- Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
- 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 90 days prior to Visit 1 (Screening) and throughout the study in either eye
- Females who are pregnant, nursing, or planning a pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Santen Inc.lead
Study Sites (17)
Sall Research Medical Center, Inc
Artesia, California, 90701, United States
North Valley Eye Medical Group
Mission Hills, California, 91345, United States
Eye Research Foundation, INC
Newport Beach, California, 92657, United States
North Bay Eye Associates, Inc.
Petaluma, California, 94954, United States
Shettle Eye Research, Inc.
Largo, Florida, 33773, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260, United States
Coastal Research Associates, LLC
Roswell, Georgia, 30076, United States
Rochester Ophthalmological Group, PC
Rochester, New York, 14618, United States
Mundorf Eye Center
Charlotte, North Carolina, 28204, United States
Cornerstone Health Care, LLC
High Point, North Carolina, 27262, United States
Keystone Research Ltd SMO/Texan Eye, PA
Austin, Texas, 78731, United States
Keystone Research LTD SMO/Medical Center Ophthalmology Assoc.
San Antonio, Texas, 78240, United States
Murakami Karindoh Hospital
Fukuoka-shi, Fukuoka, Japan
Nagasaka Eye Clinic
Nagoya-shi, Aichi, Japan
Sugiura Eye Clinic
Osaka-shi, Osaka, Japan
Sapporo Katoh Ophthalmology Clinic
Sapporo-shi, Hokkaido, Japan
Dogenzaka Kato Eye Clinic
Shibuya-ku, Tokyo, Japan
Related Publications (1)
Wirta DL, Kuwayama Y, Lu F, Shao H, Odani-Kawabata N. Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study. J Ocul Pharmacol Ther. 2022 Apr;38(3):240-251. doi: 10.1089/jop.2021.0077. Epub 2022 Feb 15.
PMID: 35167779DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- R&D Quality Manager
- Organization
- Santen Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 13, 2017
Study Start
July 25, 2017
Primary Completion
February 27, 2018
Study Completion
February 27, 2018
Last Updated
October 23, 2020
Results First Posted
October 23, 2020
Record last verified: 2020-09