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Phase 3 Study of EBI-005 in Dry Eye Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase 3 Study of EBI-005 in Dry Eye Disease

A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Contraol In Subjects With Moderate to Severe Dry Eye Disease

NCT01998802•Eleven Biotherapeutics

View on ClinicalTrials.gov

Summary

This is a phase III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
•Are ≥ 18 years of age;
•Are willing and able to follow instructions and can be present for the required study visits for the duration of the study;
•Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis
•Have normal lid anatomy.
•If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1

Exclusion Criteria

•Have signs of infection (i.e., fever or current treatment with antibiotics)
•Have been exposed to an investigational drug/device within the preceding 30 days
•Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
•Be unwilling to or unable to comply with the study

Locations (45)

Investigational Site

Chandler, Arizona, United States

Investigational Site

Mesa, Arizona, United States

Investigational Site

Little Rock, Arkansas, United States

Investigational Site

Artesia, California, United States

Investigational Site

Mission Hills, California, United States

Investigational Site

Petaluma, California, United States

Investigational Site

Rancho Cordova, California, United States

Investiational Site

San Diego, California, United States

Investigational Site

Torrence, California, United States

Investigational Site

Littleton, Colorado, United States

Key Dates

Start Date

January 1, 2014

Primary Completion Date

March 1, 2015

Completion Date

April 1, 2015

Last Updated

June 11, 2015

Enrollment

670

ACTUAL participants

Conditions

Dry Eye Disease (DED)

Interventions

Active Comparator EBI-005

DRUG

Placebo Comparator

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITINGPHASE4

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

NCT07396441

Juvenile Open Angle GlaucomaDry Eye Disease (DED)+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 3 Study of EBI-005 in Dry Eye Disease

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Role of Corneal Nerves in Dry Eye Disease

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT

A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye