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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.

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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

FieldValue
Enrollment Target 60 participants
Start Date 2012-07
Est. Completion 2012-11
Phase Phase 1

Sponsor

Santen

32 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.