A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis (EBI-005-AC-2)

Eleven Biotherapeutics

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis (AC)

Treatments: Drug: Placebo Comparator; Drug: EBI-005

Study type: Interventional

Funder types: Industry

Identifiers

NCT02492321

EBI-005-AC-2

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups, including a placebo group

EBI-005

Active Comparator group

Description:

Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day

Treatment:

Drug: EBI-005

Vehicle

Placebo Comparator group

Description:

Placebo Comparator: One of two study arms: placebo topical administered 3 times per day

Treatment:

Drug: Placebo Comparator