Skip to main content
OpenTrials
Completed

NCT Number: NCT02492321

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Conjunctivitis (AC) Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Morrow, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EBI-005

Drug

placebo comparator

Drug

Primary outcomes

  1. Morning ocular itching diary scores

    Time frame: 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 outcomes

  1. Late afternoon ocular itching diary scores

    Time frame: 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

  2. Evening ocular itching diary scores

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eleven Biotherapeutics

Industry

Registry information

Official study title

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

Acronym: EBI-005-AC-2

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2015
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.