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

NCT ID: NCT02405039

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

EBI-005

Intervention Type DRUG

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

Placebo or Vehicle control Comparator

One of two study arms: placebo or vehicle control topical administered 3 times per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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EBI-005

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eleven Biotherapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Goldstein, MD

Role: STUDY_DIRECTOR

Eleven Biotherapeutics

Locations

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Birmingham, Alabama, United States

Site Status

Newport Beach, California, United States

Site Status

Hamden, Connecticut, United States

Site Status

New Albany, Indiana, United States

Site Status

Louisville, Kentucky, United States

Site Status

Winchester, Massachusetts, United States

Site Status

St Louis, Missouri, United States

Site Status

Asheville, North Carolina, United States

Site Status

Mason, Ohio, United States

Site Status

Cranberry Township, Pennsylvania, United States

Site Status

Memphis, Tennessee, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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EBI-005-4

Identifier Type: -

Identifier Source: org_study_id

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