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

Eleven Biotherapeutics188 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

188

Conditions

Dry Eye

Interventions

EBI-005DRUG

EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day

PlaceboDRUG

Placebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Newport Beach, California, United States

Unnamed facility

Hamden, Connecticut, United States

Unnamed facility

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 1 year

Safety of EBI-005 (laboratory changes over time)

Time frame: 1 year

Secondary Outcomes

Biological effect of EBI-005 (Changes over time in the OSDI)

Changes over time in the OSDI.

Time frame: 1 year

Biological effect of EBI-005 (Total corneal fluorescein staining)

Time frame: 1 year

Data from ClinicalTrials.gov

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