A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
NCT ID: NCT03216902
Last Updated: 2020-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
241 participants
INTERVENTIONAL
2017-07-25
2018-02-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Placebo (Vehicle of DE-126) followed by high dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
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
Ultra-low dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Low dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Medium dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
High dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
Interventions
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Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
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
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical low dose of DE-126 Ophthalmic Solution
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical medium dose of DE-126 Ophthalmic Solution
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical high dose of DE-126 Ophthalmic Solution
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0.005% Latanoprost Ophthalmic Solution
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Sall Research Medical Center, Inc
Artesia, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
Eye Research Foundation, INC
Newport Beach, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Shettle Eye Research, Inc.
Largo, Florida, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
Cornerstone Health Care, LLC
High Point, North Carolina, United States
Keystone Research Ltd SMO/Texan Eye, PA
Austin, Texas, United States
Keystone Research LTD SMO/Medical Center Ophthalmology Assoc.
San Antonio, Texas, 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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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012601IN
Identifier Type: -
Identifier Source: org_study_id
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