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NCT01654484 · ClinicalTrials.gov registry record · Phase 1
A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
A Phase 1 study, sponsored by Santen.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01654484 is a Phase 1 study that has completed, run by Santen. The registered enrollment target is 60 participants.
The verdict
NCT01654484, a Phase 1 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.
Interventions
- DRUG Placebo
- DRUG DE-117
- DRUG 0.0015% tafluprost
- DRUG DE-117 and 0.0015% tafluprost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-07 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01654484
The ClinicalTrials.gov registry entry for NCT01654484 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 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 4 interventions - of which Placebo is the first listed.
NCT01654484 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01654484 about?
NCT01654484 is a clinical study titled "A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT". The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle gla...
What is the current status of trial NCT01654484?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-07. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01654484?
The interventions under investigation include: Placebo (DRUG), DE-117 (DRUG), 0.0015% tafluprost (DRUG), DE-117 and 0.0015% tafluprost (DRUG).
Who is sponsoring clinical trial NCT01654484?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
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