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

Phase 3

• Conditions: Dry Eye
• Interventions: Drug: EBI-005; Drug: Placebo

• Registration Number: NCT02405039
• Lead Sponsor: Eleven Biotherapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-03-27
• Study Start: 2015-04
• Study First Posted: 2015-04-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-04
• Primary Completion: 2016-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: EBI-005	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
Placebo or Vehicle control Comparator	Placebo	One of two study arms: placebo or vehicle control topical administered 3 times per day

Primary Outcome Measures

Name	Time	Method
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 (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.
Safety of EBI-005 (laboratory changes over time)	1 year

Secondary Outcome Measures

Name	Time	Method
Biological effect of EBI-005 (Total corneal fluorescein staining)	1 year
Biological effect of EBI-005 (Changes over time in the OSDI)	1 year	Changes over time in the OSDI.