A Multi-Center Study Subjects With Dry Eye Syndrome (EBI)

Eleven Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Dry Eye Syndrome

Treatments: Drug: EBI-005-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01745887

EBI-005-2

Details and patient eligibility

About

This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the United States (US). Subjects will be enrolled in two groups or cohorts. The first enrollment group will consist of 33 subjects.

Full description

• To investigate the safety and tolerability of EBI-005 ophthalmic solution compared to placebo in the treatment of patients with moderate to severe Dry Eye Syndrome (DES).
• To evaluate pharmacokinetic (PK) parameters and immunogenicity of two different doses of EBI-005 ophthalmic solution.
• To investigate the biological activity of multiple doses of EBI-005 ophthalmic solution compared to placebo as assessed by both objective and subjective assessments.
• To investigate the comparative dose response of two different doses of EBI-005 ophthalmic solution.
• To investigate the comparative tolerability of two different doses of EBI-005 ophthalmic solution.
• To identify key biomarkers in the diagnosis and management of subjects with DES.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Provide written informed consent prior to any study related procedures

• Are 18 years of age or older

• Are women of child bearing potential (WOCBP) who are non-pregnant, non-lactating and sexually inactive (abstinent) for 14 days prior to Visit 1

• Are willing and able to follow instructions and can be present for the required study visits for the duration of the study

• Have a history of Dry Eye Syndrome in both eyes supported by a previous clinical diagnosis

• Have ongoing Dry Eye Syndrome, in the same eye or both eyes, as defined by the following criteria:

  1. A score of ≥23 on OSDI
  2. A corneal fluorescein staining score of ≥6 (NEI scale)

• Have normal lid anatomy

• Are willing to withhold artificial tears for the duration of the study, with the exception of the study provided artificial tears: Refresh Plus®.

Exclusion Criteria: Subjects may not:

• Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept or Ilaris).
• Have an OSDI score ≥90
• Have a corneal fluorescein staining score of 15 (NEI scale). NOTE: If one of two eyes has a corneal fluorescein staining score of 15, the subject may be eligible.
• Within 30 days prior to the screening visit (Visit 1) have taken: Topical cyclosporine (Restasis®) Ocular corticosteroids Autologous serum Topical ocular antibiotics Topical ocular antihistamines or mast cell stabilizers Topical or nasal vasoconstrictors
• Within 30 days prior to the screening visit (Visit 1) have altered the dose of tetracycline compounds (tetracycline, doxycycline or minocycline).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 3 patient groups, including a placebo group

EBI-005-2 5mg/ml

Active Comparator group

Description:

Administration: 3 times per day

Treatment:

Drug: EBI-005-2

EBI-005-2 20 mg/ml

Active Comparator group

Description:

Administration: 3 times per day

Treatment:

Drug: EBI-005-2

EBI-005-2 Placebo

Placebo Comparator group

Description:

Administration: 3 times per day