A Multi-Center Study Subjects With Dry Eye Syndrome

Completed · Phase 1 · Has a placebo group

Conditions studied: Dry Eye Syndrome

In brief

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.

Key facts

Study ID

NCT01745887

Run by

Eleven Biotherapeutics

People needed

74

Starts

2012-11-01

Expected to finish

2012-11-01

Last updated by the study team

2013-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• A score of ≥23 on OSDI
• 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).

Where it is running

• Investigational Site — Artesia, California, United States
• Investigational Site — Ranchero Cordova, California, United States
• Investigational Site — Torrence, California, United States
• Investigational Site — Kansas City, Missouri, United States
• Investigational Site — Washington, Missouri, United States
• Investigational Site — Cleveland, Ohio, United States
• Investigational Site — San Antonio, Texas, United States
• Investigational Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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