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
Public ClinicalTrials.gov record NCT04742283. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IIb, Randomized, Double-Masked, Active-Controlled, Parallel-Group, 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04742283
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 323 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 16, 2020
- Primary completion
- Dec 6, 2021
- Completion
- Dec 6, 2021
- Last update posted
- Jun 21, 2023
2020 – 2021
United States locations
- U.S. sites
- 41
- U.S. states
- 18
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85224 | — |
| Arizona Glaucoma Specialists | Phoenix | Arizona | 85050 | — |
| Walman Eye Center | Sun City | Arizona | 85351-3019 | — |
| Global Research Management | Glendale | California | 91204-2569 | — |
| Premiere Practice Management | Los Angeles | California | 90013 | — |
| North Valley Eye Medical Group | Mission Hills | California | 91342 | — |
| The Eye Research Foundation | Newport Beach | California | 92663-3642 | — |
| University of California, Los Angeles, Doheny Eye Centers | Pasadena | California | 91105 | — |
| North Bay Eye Associates, Inc | Petaluma | California | 94954 | — |
| Sacramento Eye Consultants | Sacramento | California | 95815-4605 | — |
| University of Colorado, Dept. of Opthamology | Aurora | Colorado | 80045 | — |
| Hernando Eye Institute | Brooksville | Florida | 34613-6065 | — |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901-9311 | — |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | — |
| Mayo Clinic, Dept. of Opthamology | Jacksonville | Florida | 32224 | — |
| Bowden Eye & Associates | Jacksonville | Florida | 32258 | — |
| Shettle Eye Research | Largo | Florida | 33773 | — |
| Dixophthal PC dba Dixon Eye Care | Albany | Georgia | 31701-2363 | — |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | — |
| Coastal Research Associates | Roswell | Georgia | 30076 | — |
| Clinical Eye Research of Boston, LLC | Winchester | Massachusetts | 01890 | — |
| Nevada Eye Care Professionals | Las Vegas | Nevada | 89119 | — |
| AdvanceMed Clinical Research-Las Vegas | Las Vegas | Nevada | 89123-2810 | — |
| Northern New Jersey Eye Institute | South Orange | New Jersey | 07079-1855 | — |
| Rochester Ophthalmological Group, P.C. | Rochester | New York | 14618 | — |
| Duke Eye Center | Durham | North Carolina | 27705 | — |
| Wake Forest Health Network Ophthamology - Oak Hollow | High Point | North Carolina | 27262-7612 | — |
| Vance Thompson Vision - ND | West Fargo | North Dakota | 58078 | — |
| Apex Eye Clinical Research, LLC | Cincinnati | Ohio | 45242 | — |
| Office of Mark J. Weiss MD | Tulsa | Oklahoma | 74104-5300 | — |
| Scott & Christie and Associates PC | Cranberry Township | Pennsylvania | 16066-6412 | — |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701-7374 | — |
| University Eye Specialists | Maryville | Tennessee | 37803-6100 | — |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120-9411 | — |
| Glaucoma Associates of Texas | Dallas | Texas | 75231-2168 | — |
| The Cataract and Glaucoma Center | El Paso | Texas | 79902 | — |
| DCT- Shah Research LLC dba Discovery Clinical Trials | Mission | Texas | 78572-2425 | — |
| San Antonio Eye Center | San Antonio | Texas | 78215-1936 | — |
| R and R Eye Research LLC | San Antonio | Texas | 78229-3539 | — |
| Stacy R. Smith M.D. P.C. | Salt Lake City | Utah | 84117-5209 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04742283, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04742283 live on ClinicalTrials.gov.