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Trials / Completed

CompletedNCT01118754

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

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
132 (estimated)
Sponsor
Santen Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGDE-101 ophthalmic suspensionOphthalmic suspention; QID
DRUGDE-101 ophthalmic suspensionOphthalmic suspension; QID
DRUGDE-101 ophthalmic suspension vehicleophthalmic suspension vehicle; QID

Timeline

Start date
2010-04-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2010-05-07
Last updated
2011-11-03

Locations

10 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01118754. Inclusion in this directory is not an endorsement.

Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients (NCT01118754) · Clinical Trials Directory