Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
- Conditions
- Primary Open-angle Glaucoma and Ocular Hypertension
- Interventions
- Drug: DE-117 Ophthalmic Solution QDDrug: DE-117 Ophthalmic Solution BID
- Registration Number
- NCT03858894
- Lead Sponsor
- Santen Inc.
- Brief Summary
This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks.
Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:
* DE-117 ophthalmic solution 0.002% QD (Once Daily)
* DE-117 ophthalmic solution 0.002% BID (Twice Daily)
This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Provide signed written informed consent
- Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
- 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
- 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 180 days prior to Screening and throughout the study in either eye
- Females who are pregnant, nursing, or planning a pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug Arm: DE-117 QD DE-117 Ophthalmic Solution QD DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD Test Arm: DE-117 BID DE-117 Ophthalmic Solution BID DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)
- Primary Outcome Measures
Name Time Method Intraocular Pressure (IOP) at Week 2 16:00 at week 2 Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Intraocular Pressure (IOP) at Week 6 16:00 at week 6 Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
- Secondary Outcome Measures
Name Time Method Mean Diurnal Intraocular Pressure (IOP) 6 weeks Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Trial Locations
- Locations (13)
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
Eye Associates/SurgiCenter of Vineland
🇺🇸Vineland, New Jersey, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
Ophthalmic Consultants of Long Island
🇺🇸Lynbrook, New York, United States
Scott & Christie and Associates PC
🇺🇸Cranberry Township, Pennsylvania, United States
University Eye Specialist
🇺🇸Maryville, Tennessee, United States
Danbury Eye Specialist
🇺🇸Danbury, Connecticut, United States
Apex Eye Clinical Research, LLC
🇺🇸Cincinnati, Ohio, United States
East West Eye Institute
🇺🇸Los Angeles, California, United States
Hernando Eye Institute
🇺🇸Brooksville, Florida, United States
Seidenberg Protzko Eye Associates
🇺🇸Havre De Grace, Maryland, United States
Advanced Vision Research
🇺🇸Nashville, Tennessee, United States