Overview

A Multi-Center Study Subjects With Dry Eye Syndrome

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eleven Biotherapeutics
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).