DE-117 Spectrum 5 Study
- Conditions
- Primary Open-angle Glaucoma and Ocular Hypertension
- Interventions
- Drug: DE-117 Ophthalmic Solution
- Registration Number
- NCT03697811
- Lead Sponsor
- Santen Inc.
- Brief Summary
Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
- 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 after latanoprost Run-in Period.
- Qualifying Anterior chamber angle.
- Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.
- Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
- Patients with prior exposure to DE-117.
- History of ocular surgery specifically intended to lower IOP
- 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 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
- Females who are pregnant, nursing, or planning a pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DE-117 Ophthalmic Solution 0.002% DE-117 Ophthalmic Solution Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3. Month 3 IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
- Secondary Outcome Measures
Name Time Method Change From Baseline in IOP at Timepoints at Week 2 08:00, 12:00 and 16:00 at Week 2 Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 week 2 and 6 Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 08:00, 12:00 and 16:00 at month 3. Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Change From Baseline in IOP at Timepoints at Week 6 08:00, 12:00 and 16:00 at Week 6 Change in mean IOP were evaluated at each time point at all post-baseline visits.
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 week 2, 6 and month 3 The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.
Change From Baseline in IOP at Timepoints at Month 3 08:00, 12:00 and 16:00 at month 3 Change in mean IOP were evaluated at each time point at all post-baseline visits.
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 08:00, 12:00 and 16:00 at week 2 Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 08:00, 12:00 and 16:00 at week 6 Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Trial Locations
- Locations (32)
Asheville Eye Associates, PLLC
🇺🇸Asheville, North Carolina, United States
Shettle Eye Research, Inc.
🇺🇸Largo, Florida, United States
Glaucoma Consultants and Center for Eye Research, PA
🇺🇸Mount Pleasant, South Carolina, United States
Total Eye Care PA
🇺🇸Memphis, Tennessee, United States
Apex Eye Clinical Research, LLC
🇺🇸Cincinnati, Ohio, United States
Dixon Eye Care
🇺🇸Albany, Georgia, United States
Heart of America Eye Care, P.A.
🇺🇸Shawnee Mission, Kansas, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
North Bay Eye Associates
🇺🇸Petaluma, California, United States
VRF Eye Specialty Group
🇺🇸Memphis, Tennessee, United States
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Global Research Management
🇺🇸Glendale, California, United States
North Valley Eye Medical Group
🇺🇸Mission Hills, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Danbury Eye Physicians & Surgeons
🇺🇸Danbury, Connecticut, United States
International Eye Associates, PA
🇺🇸Ormond Beach, Florida, United States
Coastal Research Associates, LEC
🇺🇸Roswell, Georgia, United States
Comprehensive Eye Care Ltd
🇺🇸Washington, Missouri, United States
NYU Langone Health Department of Ophthalmology
🇺🇸New York, New York, United States
Rochester Ophthalmological Group, PC
🇺🇸Rochester, New York, United States
Clayton Eye Clinical Research, LLC
🇺🇸Morrow, Georgia, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
South Shore Eye Center
🇺🇸Wantagh, New York, United States
Mundorf Eye Center
🇺🇸Charlotte, North Carolina, United States
Cornerstone Health Care
🇺🇸High Point, North Carolina, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
Scott & Christie and Associates PC
🇺🇸Cranberry Township, Pennsylvania, United States
The Eye Institute
🇺🇸Tulsa, Oklahoma, United States
Texas Eye, PA
🇺🇸Austin, Texas, United States
Eye Clinic of Texas
🇺🇸League City, Texas, United States
Nashville Vision Associates
🇺🇸Nashville, Tennessee, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States