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A Multi-Center Study Subjects With Dry Eye Syndrome

NCT01745887 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2013-08-14

No results posted yet for this study

Summary

This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the United States (US). Subjects will be enrolled in two groups or cohorts. The first enrollment group will consist of 33 subjects.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

EBI-005-2

The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.

Sponsors & Collaborators

  • Eleven Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • Michael Goldstein, MD · Eleven Biotherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01745887 on ClinicalTrials.gov