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
Completed · Phase 2
Conditions studied: Primary Open-angle Glaucoma and Ocular Hypertension
In brief
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.
Key facts
- Study ID
- NCT03858894
- Run by
- Santen Inc.
- People needed
- 98
- Starts
- 2019-01-28
- Expected to finish
- 2019-06-20
- Last updated by the study team
- 2020-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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 180 days prior to Screening and throughout the study in either eye
- Females who are pregnant, nursing, or planning a pregnancy
Where it is running
- East West Eye Institute — Los Angeles, California, United States
- Danbury Eye Specialist — Danbury, Connecticut, United States
- Hernando Eye Institute — Brooksville, Florida, United States
- Levenson Eye Associates — Jacksonville, Florida, United States
- Seidenberg Protzko Eye Associates — Havre de Grace, Maryland, United States
- Tekwani Vision Center — St Louis, Missouri, United States
- Eye Associates/SurgiCenter of Vineland — Vineland, New Jersey, United States
- Ophthalmic Consultants of Long Island — Lynbrook, New York, United States
- Apex Eye Clinical Research, LLC — Cincinnati, Ohio, United States
- Abrams Eye Center — Cleveland, Ohio, United States
- Scott & Christie and Associates PC — Cranberry Township, Pennsylvania, United States
- University Eye Specialist — Maryville, Tennessee, United States
- Advanced Vision Research — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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