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NCT03216902 · ClinicalTrials.gov registry record · Phase 2
A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
A Phase 2 study, sponsored by Santen.
- Completed
- Registry status
- Phase 2
- Development phase
- 241
- Enrollment target
NCT03216902: Completed Phase 2 study, sponsored by Santen.
NCT03216902 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 241 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03216902, a Phase 2 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 241 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Interventions
- DRUG 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2017-07-25 |
| Est. Completion | 2018-02-27 |
| Phase | Phase 2 |
What the finished NCT03216902 record still lists
NCT03216902 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% higher).
The record links to 0 conditions, and to 5 interventions - of which Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution is the first listed.
NCT03216902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03216902 about?
NCT03216902 is a clinical study titled "A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study". 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 co...
What is the current status of trial NCT03216902?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 241 participants. The study started on 2017-07-25. Estimated completion is 2018-02-27.
What interventions are being tested in trial NCT03216902?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03216902?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03216902's enrollment target sits among peer trials
241 239th of 2000 higher than 1,762 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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