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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02492321

Acronym

EBI-005-AC-2

Enrollment

250

Registered

2015-07-08

Start date

2015-07-31

Completion date

2015-12-31

Last updated

2016-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis (AC)

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.

Interventions

DRUGEBI-005

DRUGPlacebo Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026