Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 241 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03216902
The ClinicalTrials.gov registry entry for NCT03216902 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Santen, which has 32 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.