A Multi-Center Study Subjects With Dry Eye Syndrome

NCT01745887 | Completed Phase 1

• 1 other identifier: EBI-005-2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 8

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.

Conditions

Dry Eye Syndrome

Keywords

Dry Eye Syndrome; Interleukin 1 Receptor Inhibitor

Outcome Measures

Primary Outcomes (1)

• OSDI (Ocular Surface Disease Index)

  OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms

  2 months

Secondary Outcomes (2)

• Change from baseline in total corneal fluorescein staining

  2 months

• Symptom Assessment in Dry Eye (Modified SANDE)

  2 months

Other Outcomes (1)

• Gene transcription levels measured from cells collected via impression cytology

  2 months

Study Arms (3)

EBI-005-2 5mg/ml

ACTIVE COMPARATOR

Administration: 3 times per day

Drug: EBI-005-2

EBI-005-2 20 mg/ml

ACTIVE COMPARATOR

Administration: 3 times per day

Drug: EBI-005-2

EBI-005-2 Placebo

PLACEBO COMPARATOR

Administration: 3 times per day

Interventions

EBI-005-2 DRUG

The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.

EBI-005-2 20 mg/ml; EBI-005-2 5mg/ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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®.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eleven Biotherapeutics: lead

Study Sites (8)

Investigational Site

Artesia, California, 90701, United States

Location

Investigational Site

Ranchero Cordova, California, 95670, United States

Location

Investigational Site

Torrence, California, 90505, United States

Location

Investigational Site

Kansas City, Missouri, 64111, United States

Location

Investigational Site

Washington, Missouri, 63090, United States

Location

Investigational Site

Cleveland, Ohio, 44115, United States

Location

Investigational Site

San Antonio, Texas, 78209, United States

Location

Investigational Site

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Michael Goldstein, MD

  Eleven Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 10, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

US (8)