A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Public ClinicalTrials.gov record NCT03216902. 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, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Treatment 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 four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 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, vital signs, and clinical laboratory tests. 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
- NCT03216902
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 241 participants
Conditions and interventions
Conditions
Interventions
- Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution Drug
- Topical ultra-low dose of DE-126 Ophthalmic Solution Drug
- Topical low dose of DE-126 Ophthalmic Solution Drug
- Topical medium dose of DE-126 Ophthalmic Solution Drug
- Topical high dose of DE-126 Ophthalmic Solution Drug
- 0.005% Latanoprost Ophthalmic Solution Drug
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
- Jul 24, 2017
- Primary completion
- Feb 26, 2018
- Completion
- Feb 26, 2018
- Last update posted
- Oct 22, 2020
2017 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sall Research Medical Center, Inc | Artesia | California | 90701 | — |
| North Valley Eye Medical Group | Mission Hills | California | 91345 | — |
| Eye Research Foundation, INC | Newport Beach | California | 92657 | — |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | — |
| Shettle Eye Research, Inc. | Largo | Florida | 33773 | — |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | — |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | — |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | — |
| Mundorf Eye Center | Charlotte | North Carolina | 28204 | — |
| Cornerstone Health Care, LLC | High Point | North Carolina | 27262 | — |
| Keystone Research Ltd SMO/Texan Eye, PA | Austin | Texas | 78731 | — |
| Keystone Research LTD SMO/Medical Center Ophthalmology Assoc. | San Antonio | Texas | 78240 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03216902, 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 Oct 22, 2020 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03216902 live on ClinicalTrials.gov.