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

Eleven Biotherapeutics250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

250

Conditions

Allergic Conjunctivitis (AC)

Interventions

EBI-005DRUG

Placebo ComparatorDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Morrow, Georgia, United States

Unnamed facility

Louisville, Kentucky, United States

Unnamed facility

Andover, Massachusetts, United States

Investigational Site

Outcomes

Primary Outcomes

Morning ocular itching diary scores

To evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season.

Time frame: 14 days

Secondary Outcomes

Late afternoon ocular itching diary scores

The key secondary endpoints are to evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season

Time frame: 14 days

Evening ocular itching diary scores

Time frame: 14 days

Data from ClinicalTrials.gov

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