Clinical trial NCT01745887: A Multi-Center Study Subjects With Dry Eye Syndrome
Official title: A Multi-Center, Double Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of EBI-005 Ophthalmic Solution Versus Placebo in Subjects With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome
Interleukin 1 Receptor Inhibitor
Lead sponsor: Eleven Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2012-12-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: OSDI (Ocular Surface Disease Index)
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline in total corneal fluorescein staining
timeFrame: 2 months
measure: Symptom Assessment in Dry Eye (Modified SANDE)
timeFrame: 2 months
Other outcomes:
measure: Gene transcription levels measured from cells collected via impression cytology
timeFrame: 2 months
Locations:
city: Artesia
country: United States
facility: Investigational Site
state: California
city: Ranchero Cordova
country: United States
facility: Investigational Site
state: California
city: Torrence
country: United States
facility: Investigational Site
state: California
city: Kansas City
country: United States
facility: Investigational Site
state: Missouri
city: Washington
country: United States
facility: Investigational Site
state: Missouri
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Investigational Site
state: Virginia
Study officials:
affiliation: Eleven Biotherapeutics
name: Michael Goldstein, MD
role: STUDY_DIRECTOR
References: