Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Completed · Phase 2
Conditions studied: Primary Open Angle Glaucoma, Ocular Hypertension
In brief
Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The IOP will be measured at 3 different times throughout the day, over 4 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, and vital signs. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
Key facts
- Study ID
- NCT04742283
- Run by
- Santen Inc.
- People needed
- 323
- Starts
- 2020-12-17
- Expected to finish
- 2021-12-07
- Last updated by the study team
- 2023-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
- Completed the required wait/washout period
- Qualifying Day 1 IOP measurement at 3 time-points in both eyes
You may not qualify if…
- Females who are pregnant, nursing, or planning a pregnancy
- Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
- History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
- Presence of advanced glaucoma in either eye
Where it is running
- Arizona Eye Center — Chandler, Arizona, United States
- Arizona Glaucoma Specialists — Phoenix, Arizona, United States
- Walman Eye Center — Sun City, Arizona, United States
- Global Research Management — Glendale, California, United States
- Premiere Practice Management — Los Angeles, California, United States
- North Valley Eye Medical Group — Mission Hills, California, United States
- The Eye Research Foundation — Newport Beach, California, United States
- University of California, Los Angeles, Doheny Eye Centers — Pasadena, California, United States
- North Bay Eye Associates, Inc — Petaluma, California, United States
- Sacramento Eye Consultants — Sacramento, California, United States
- University of Colorado, Dept. of Opthamology — Aurora, Colorado, United States
- Hernando Eye Institute — Brooksville, Florida, United States
- Eye Associates of Fort Myers — Fort Myers, Florida, United States
- Levenson Eye Associates — Jacksonville, Florida, United States
- Mayo Clinic, Dept. of Opthamology — Jacksonville, 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
- Clayton Eye Clinical Research, LLC — Morrow, Georgia, United States
- Coastal Research Associates — Roswell, Georgia, United States
- Clinical Eye Research of Boston, LLC — Winchester, Massachusetts, United States
- Nevada Eye Care Professionals — 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
- Rochester Ophthalmological Group, P.C. — Rochester, New York, United States
Full record on ClinicalTrials.gov
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