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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: Completed Phase 1 study, sponsored by Santen.
NCT01654484 is a Phase 1 study that has completed, run by Santen. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01654484 record still lists
NCT01654484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01654484 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01654484's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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