A Multi-Center Study Subjects With Dry Eye Syndrome
- Registration Number
- NCT01745887
- Lead Sponsor
- Eleven Biotherapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
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Provide written informed consent prior to any study related procedures
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Are 18 years of age or older
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Are women of child bearing potential (WOCBP) who are non-pregnant, non-lactating and sexually inactive (abstinent) for 14 days prior to Visit 1
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Are willing and able to follow instructions and can be present for the required study visits for the duration of the study
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Have a history of Dry Eye Syndrome in both eyes supported by a previous clinical diagnosis
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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)
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Have normal lid anatomy
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Are willing to withhold artificial tears for the duration of the study, with the exception of the study provided artificial tears: Refresh Plus®.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EBI-005-2 5mg/ml EBI-005-2 Administration: 3 times per day EBI-005-2 20 mg/ml EBI-005-2 Administration: 3 times per day
- Primary Outcome Measures
Name Time Method OSDI (Ocular Surface Disease Index) 2 months OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms
- Secondary Outcome Measures
Name Time Method Symptom Assessment in Dry Eye (Modified SANDE) 2 months Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.
Change from baseline in total corneal fluorescein staining 2 months Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.
Trial Locations
- Locations (1)
Investigational Site
🇺🇸Norfolk, Virginia, United States