Clinical trial NCT03216902: A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma, Ocular Hypertension
Keywords: Glaucoma
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-13
Enrollment: 241
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intraocular Pressure in the Study Eye at Month 3
timeFrame: 9:00, 13:00 and 17:00 at Month 3
Secondary outcomes:
measure: Intraocular Pressure in the Study Eye at Week 6
timeFrame: 9:00, 13:00 and 17:00 at Week 6
measure: Intraocular Pressure in the Study Eye at Week 1 and Week 2
timeFrame: 9:00, 13:00 and 17:00 at Week 1 and Week 2
measure: Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
timeFrame: Week 1, Week 2, Week 6 and Month 3.
measure: Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
timeFrame: Week 1, Week 2, Week 6 and Month 3.
measure: Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
timeFrame: Week 1, Week 2, Week 6 and Month 3.
measure: Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
timeFrame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
measure: Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
timeFrame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
measure: Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
timeFrame: WeeK 1, Week 2, Week 6 and Month 3.
measure: Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
timeFrame: Week 1, Week 2, Week 6 and Month 3.
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center, Inc
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation, INC
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Largo
country: United States
facility: Shettle Eye Research, Inc.
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Health Care, LLC
state: North Carolina
city: Austin
country: United States
facility: Keystone Research Ltd SMO/Texan Eye, PA
state: Texas
city: San Antonio
country: United States
facility: Keystone Research LTD SMO/Medical Center Ophthalmology Assoc.
state: Texas
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Murakami Karindoh Hospital
city: Nagoya-shi, Aichi
country: Japan
facility: Nagasaka Eye Clinic
city: Osaka-shi, Osaka
country: Japan
facility: Sugiura Eye Clinic
city: Sapporo-shi, Hokkaido
country: Japan
facility: Sapporo Katoh Ophthalmology Clinic
city: Shibuya-ku, Tokyo
country: Japan
facility: Dogenzaka Kato Eye Clinic
Study officials:
References:
citation: 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.