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

Dry Eye Clinical Trial

— EBI-005  

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02405039
• Other study ID #: EBI-005-4
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 6, 2015
• Last updated: June 2, 2015
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2015
• Source: Eleven Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eleven Biotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Safety of EBI-005 (laboratory changes over time)		1 year	Yes
Secondary	Biological effect of EBI-005 (Changes over time in the OSDI)	Changes over time in the OSDI.	1 year	No
Secondary	Biological effect of EBI-005 (Total corneal fluorescein staining)		1 year	No