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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01468168

Public ClinicalTrials.gov record NCT01468168. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 8:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.

Study identification

NCT ID
NCT01468168
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Santen Inc.
Industry
Enrollment
183 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2011
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012
Last update posted
Dec 16, 2012

2011 – 2012

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
Not listed New Port Beach California 92663
Not listed Parker Colorado 80134
Not listed Largo Florida 33773
Not listed Morrow Georgia 30260
Not listed Roswell Georgia 30076
Not listed Bangor Maine 04401
Not listed Kansas City Missouri 64111
Not listed St Louis Missouri 63131
Not listed Washington Missouri 63090
Not listed High Point North Carolina 27262
Not listed Cleveland Ohio 44115
Not listed Salt Lake City Utah 84107
Not listed Norfolk Virginia 23507

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01468168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 16, 2012 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01468168 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →