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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eleven Biotherapeutics

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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