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A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis

NCT02492321 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2016-02-11

No results posted yet for this study

Summary

This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks.

Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled into the study.

Conditions

  • Allergic Conjunctivitis (AC)

Interventions

DRUG

EBI-005

DRUG

Placebo Comparator

Sponsors & Collaborators

  • Eleven Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • Michael Goldstein, MD · Eleven Biotherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-11-30
Completion
2015-12-31

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 NCT02492321 on ClinicalTrials.gov