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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Evaluation of the Efficacy, Safety, and Tolerability of EBI-005 in Subjects With Moderate to Severe Ocular Allergic Conjunctivitis

Conditions
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Allergic Conjunctivitis (AC)

Intervention / Treatment
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* Drug: EBI-005
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EBI-005<br>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 | Drug: EBI-005<br> <br> |
| Placebo Comparator: Vehicle<br>Placebo Comparator: One of two study arms: placebo topical administered 3 times per day | Drug: Placebo Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 days | 
| Evening 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 | 14 days |