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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-31

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.

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Detailed Description

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Conditions

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Allergic Conjunctivitis (AC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

EBI-005

Intervention Type DRUG

Vehicle

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

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Interventions

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EBI-005

Intervention Type DRUG

Placebo Comparator

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No