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Completed

NCT Number: NCT01745887

A Multi-Center Study Subjects With Dry Eye Syndrome

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, Artesia, California, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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).

Treatment and study plan

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.

Primary outcomes

  1. OSDI (Ocular Surface Disease Index)

    Time frame: 2 months

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

Secondary outcomes

  1. Change from baseline in total corneal fluorescein staining

    Time frame: 2 months

    Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.

  2. Symptom Assessment in Dry Eye (Modified SANDE)

    Time frame: 2 months

    Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.

Other outcomes

  1. Gene transcription levels measured from cells collected via impression cytology

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Eleven Biotherapeutics

Industry

Registry information

Official study 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

Acronym: EBI

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 10, 2012
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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