A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
Completed · Phase 3
Conditions studied: Glaucoma and Ocular Hypertension
In brief
This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of 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 baseline will be randomized to receive double-masked treatment for 3 months. Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: * DE-117 Ophthalmic Solution once daily and Vehicle once daily, or * Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.
Key facts
- Study ID
- NCT03691662
- Run by
- Santen Inc.
- People needed
- 417
- Starts
- 2018-09-27
- Expected to finish
- 2019-10-23
- Last updated by the study team
- 2023-08-09
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- glaucoma or ocular hypertension
You may not qualify if…
- Females who are pregnant, nursing, or planning a pregnancy
- Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
Where it is running
- Arizona Eye Center — Chandler, Arizona, United States
- M & M Eye Institute — Prescott, Arizona, United States
- Global Research Management — Glendale, California, United States
- United Medical Research Inst — Inglewood, California, United States
- Eye Research Foundation — Newport Beach, California, United States
- North Bay Eye Associates Inc. — Petaluma, California, United States
- Sacramento Eye Consultants — Sacramento, California, United States
- AdvanceMed Clinical Research — San Diego, California, United States
- Michael K. Tran, MD, Inc. — Westminster, California, United States
- Haas Vision Center — Colorado Springs, Colorado, United States
- Florida Ophthalmic Institute — Gainesville, Florida, United States
- St. Michaels Eye Laser Institute — Largo, Florida, United States
- International Eye Associates PA — Ormond Beach, Florida, United States
- East Florida Eye Institute — Stuart, Florida, United States
- Clayton Eye Clinical Research, LLC — Morrow, Georgia, United States
- Seidenberg Protzko Eye Associates — Havre de Grace, Maryland, United States
- Great Lakes Eye Care P.C — Saint Joseph, Michigan, United States
- Discover Vision Centers — Independence, Missouri, United States
- Silverstein Eye Centers — Kansas City, Missouri, United States
- Comprehensive Eye Care Ltd. — Washington, Missouri, United States
- AdvanceMed Clinical Research — Las Vegas, Nevada, United States
- Rochester Ophthalmological Group, PC — Rochester, New York, United States
- Asheville Eye Associates — Asheville, North Carolina, United States
- Abrams Eye Center — Cleveland, Ohio, United States
- Total Eye Care PA — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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