Study of EBI-005 in Dry Eye Disease (DED) (EBI-005)

A Multi-Center, Double-Masked, Randomized, One-Year Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle-Control in Subjects With Dry Eye Disease (DED)

This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.

Study Overview

• Status: Unknown
• Conditions: Dry Eye
• Intervention / Treatment: Drug: EBI-005; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
  • California
    • Newport Beach, California, United States, 92663
  • Connecticut
    • Hamden, Connecticut, United States, 06518
  • Indiana
    • New Albany, Indiana, United States, 47150
  • Kentucky
    • Louisville, Kentucky, United States, 40206
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
  • Missouri
    • St. Louis, Missouri, United States, 63131
  • North Carolina
    • Asheville, North Carolina, United States, 28803
  • Ohio
    • Mason, Ohio, United States, 45040
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
  • Tennessee
    • Memphis, Tennessee, United States, 38119
  • Texas
    • San Antonio, Texas, United States, 78229

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months prior to Visit 1
2. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study

Key Exclusion Criteria:

1. Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc)
2. Have had penetrating intraocular surgery within 12 months prior to Visit 1
3. Be unwilling to comply with the study requirements

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: 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	Drug: EBI-005; EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day
Placebo Comparator: Placebo or Vehicle control Comparator; One of two study arms: placebo or vehicle control topical administered 3 times per day	Drug: Placebo; Placebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EBI-005 (vital signs)	Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.	1 year
tolerability of EBI-005 (adverse events)	Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.	1 year
Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time)	Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.	1 year
Safety of EBI-005 (laboratory changes over time)		1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological effect of EBI-005 (Changes over time in the OSDI)	Changes over time in the OSDI.	1 year
Biological effect of EBI-005 (Total corneal fluorescein staining)		1 year

Collaborators and Investigators

• Sponsor: Eleven Biotherapeutics

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: January 6, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Estimate): June 4, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: DED; Disease
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: EBI-005-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No