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

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)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02405039

Acronym

EBI-005

Enrollment

188

Registered

2015-04-01

Start date

2015-04-30

Completion date

2016-07-31

Last updated

2015-06-04

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

Conditions

Dry Eye

Keywords

DED, Disease

Brief summary

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.

Interventions

DRUGEBI-005

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

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