Dry Eye Syndrome
Conditions
Keywords
Dry Eye Syndrome, Interleukin 1 Receptor Inhibitor
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.
Interventions
DRUGEBI-005-2
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.
Sponsors
Eleven Biotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OSDI (Ocular Surface Disease Index) | 2 months | OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Symptom Assessment in Dry Eye (Modified SANDE) | 2 months | Patient Reported Outcome using a Visual Analog Scale for Modified SANDE. |
Other
| Measure | Time frame |
|---|---|
| Gene transcription levels measured from cells collected via impression cytology | 2 months |
Countries
United States
Outcome results
None listed