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NCT01118754 · ClinicalTrials.gov registry record · Phase 1

Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

A Phase 1 study of Dry Eye, sponsored by Santen.

Completed
Registry status
Phase 1
Development phase
132
Enrollment target
10
Study locations

NCT01118754 is a Phase 1 study of Dry Eye that has completed, run by Santen. The registered enrollment target is 132 participants, above the 93-participant average among 41 other Dry Eye trials with a reported enrollment target (42% higher). The trial reports 10 study locations across 8 states.

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The verdict

NCT01118754, a Phase 1 study of Dry Eye, has completed, sponsored by Santen.

COMPLETED
Registry status
Phase 1
Development phase
132 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.

Conditions Studied

Interventions

  • DRUG DE-101 ophthalmic suspension
  • DRUG DE-101 ophthalmic suspension vehicle

Study Locations (10)

California

  • - Inglewood
  • - Torrance

Indiana

  • - Indianapolis
  • - New Albany

Connecticut

  • - Bloomfield

Louisiana

  • - Gretna

Maine

  • - Bangor

Ohio

  • - Cleveland

Pennsylvania

  • - Philadelphia

Texas

  • - San Antonio

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2010-04
Est. Completion 2010-12
Phase Phase 1

Sponsor

Santen

32 total trials

What the Registry Record Tells You About NCT01118754

The ClinicalTrials.gov registry entry for NCT01118754 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 93-participant average among 41 other Dry Eye trials with a reported enrollment target (42% higher). The listed sponsor is Santen, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Dry Eye appearing as the primary indexed condition, and to 2 interventions - of which DE-101 ophthalmic suspension is the first listed.

NCT01118754 reports 10 study locations spanning 8 distinct geographic areas - top geographies include California, Indiana, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01118754 about?

NCT01118754 is a clinical study titled "Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients". The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.

What is the current status of trial NCT01118754?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2010-04. Estimated completion is 2010-12.

What conditions does trial NCT01118754 study?

This clinical trial studies the following conditions: Dry Eye.

What interventions are being tested in trial NCT01118754?

The interventions under investigation include: DE-101 ophthalmic suspension (DRUG), DE-101 ophthalmic suspension vehicle (DRUG).

Who is sponsoring clinical trial NCT01118754?

This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01118754 being conducted?

This trial has 10 study locations across California, Connecticut, Indiana, Louisiana, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.