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

Completed · Phase 3 · Has a placebo group

Conditions studied: Allergic Conjunctivitis (AC)

In brief

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.

Key facts

Study ID

NCT02492321

Run by

Eleven Biotherapeutics

People needed

250

Starts

2015-07-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Give written informed consent and any authorization required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
• Are ≥18 years of age;
• Have a positive history of ocular allergies during ragweed pollen season;
• Have signs and symptoms of allergic conjunctivitis in both eyes;
• If female and of child-bearing potential, she must not be pregnant or lactating

You may not qualify if…

• Have signs of ocular infection;
• Have a known history of alcohol or drug abuse;
• Have been exposed to an investigational drug or device within 30 days of the study;
• Have planned surgery (ocular or systemic) during the trial period or within 30 days after

Where it is running

• Study site — Morrow, Georgia, United States
• Study site — Louisville, Kentucky, United States
• Study site — Andover, Massachusetts, United States
• Investigational Site — Quincy, Massachusetts, United States
• Investigational Site — St Louis, Missouri, United States
• Study site — Charlotte, North Carolina, United States
• Investigational Site — Cincinnati, Ohio, United States
• Investigational Site — Mason, Ohio, United States
• Investigational Site — Philadelphia, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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