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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis (AC)
• Interventions: Drug: Placebo Comparator; Drug: EBI-005

• Registration Number: NCT02492321
• Lead Sponsor: Eleven Biotherapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-08
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Placebo Comparator	Placebo Comparator: One of two study arms: placebo topical administered 3 times per day
EBI-005	EBI-005	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

Primary Outcome Measures

Name	Time	Method
Morning ocular itching diary scores	14 days	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.

Secondary Outcome Measures

Name	Time	Method
Late afternoon ocular itching diary scores	14 days	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
Evening ocular itching diary scores	14 days	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

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States