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 3 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. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 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 and will provide additional safety data through Month 12 for subjects receiving DE-117.
Key facts
- Study ID
- NCT03691649
- Run by
- Santen Inc.
- People needed
- 426
- Starts
- 2018-09-14
- Expected to finish
- 2020-09-03
- Last updated by the study team
- 2023-08-30
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 Glaucoma Specialists — Phoenix, Arizona, United States
- DocTrials Walman Eye Center — Sun City, Arizona, United States
- Havana Research Institute — Burbank, California, United States
- Macy Eye Center — Los Angeles, California, United States
- North Valley Eye Medical Group — Mission Hills, California, United States
- North Bay Eye Associates, Inc — Petaluma, California, United States
- Martel Eye Medical Group — Rancho Cordova, California, United States
- Samsum Clinic (DocTrials) — Santa Barbara, California, United States
- MCB Clinical Research Centers LLC — Colorado Springs, Colorado, United States
- Hernando Eye Institute — Brooksville, Florida, United States
- Eye Associates of Fort Myers — Fort Myers, Florida, United States
- Bowden Eye & Associates — Jacksonville, Florida, United States
- Shettle Eye Research — Largo, Florida, United States
- Dixophthal PC Dba. Dixon Eye Care — Albany, Georgia, United States
- Coastal Research Associates — Alpharetta, Georgia, United States
- Clayton Eye Clinical Research, LLC — Morrow, Georgia, United States
- Indiana University — Bloomington, Indiana, United States
- Heart of America Eye Care, P.A. — Shawnee Mission, Kansas, United States
- Clinical Eye Research of Boston, LLC — Winchester, Massachusetts, United States
- Tauber Eye Center — Kansas City, Missouri, United States
- Nevada Eye Care Professionals — Las Vegas, Nevada, United States
- Wellish Vision Institute — Las Vegas, Nevada, United States
- AdvanceMed Clinical Research-Las Vegas — Las Vegas, Nevada, United States
- Northern New Jersey Eye Institute — South Orange, New Jersey, United States
- NY Eye & ear Infirmary of Mt Sinai (NYEE) — New York, New York, United States
Full record on ClinicalTrials.gov
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