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

Eleven Biotherapeutics

Status and phase: Unknown; Phase 3

Conditions: Dry Eye

Treatments: Drug: EBI-005; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02405039

EBI-005-4

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

188 participants in 2 patient groups, including a placebo group

Active Comparator: EBI-005

Active Comparator group

Description:

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

Treatment:

Drug: EBI-005

Placebo or Vehicle control Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo