Dry Eye SyndromePhase 1EBINCT01745887
A Multi-Center Study Subjects With Dry Eye Syndrome
A Phase 1 study testing EBI-005-2 in people with Dry Eye Syndrome, run by Eleven Biotherapeutics at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- EBI-005-2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2012to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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®.
Who cannot join
- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Investigational Site
Artesia, California, 90701
Investigational Site
Cleveland, Ohio, 44115
Investigational Site
Kansas City, Missouri, 64111
Investigational Site
Norfolk, Virginia, 23502
Investigational Site
Ranchero Cordova, California, 95670
Investigational Site
San Antonio, Texas, 78209
Investigational Site
Torrence, California, 90505
Investigational Site
Washington, Missouri, 63090
About this study
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
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.
Read the 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.
- Conditions
- Dry Eye Syndrome
- Being tested
- EBI-005-2
- Keywords
- Dry Eye Syndrome, Interleukin 1 Receptor Inhibitor
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBI-005-2Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| EBI-005-2 5mg/ml | Active comparator | Administration: 3 times per day Receives: Drug: EBI-005-2 |
| EBI-005-2 20 mg/ml | Active comparator | Administration: 3 times per day Receives: Drug: EBI-005-2 |
| EBI-005-2 Placebo | Placebo comparator | Administration: 3 times per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI (Ocular Surface Disease Index)
OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms
Measured: 2 months
Secondary outcomes (2)
Change from baseline in total corneal fluorescein staining
Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.
Measured: 2 months
Symptom Assessment in Dry Eye (Modified SANDE)
Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleven Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Goldstein, MD, Study director, Eleven Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745887
- Sponsor's protocol ID
- EBI-005-2
- Acronym
- EBI
- Status last verified
- Aug 2013
- First submitted
- 4 Dec 2012
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01745887
- Acronym / sponsor ID
- EBI / EBI-005-2
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye Syndrome, Interleukin 1 Receptor Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Eleven BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EBI-005-2 5mg/ml | Active comparator | Drug: EBI-005-2Administration: 3 times per day |
| EBI-005-2 20 mg/ml | Active comparator | Drug: EBI-005-2Administration: 3 times per day |
| EBI-005-2 Placebo | Placebo comparator | –Administration: 3 times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBI-005-2The 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. | Drug | EBI-005-2 20 mg/ml, EBI-005-2 5mg/ml |
Primary outcome
OSDI (Ocular Surface Disease Index)
Time frame: 2 months
OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms
2 secondary outcomes
Change from baseline in total corneal fluorescein staining
Time frame: 2 months
Symptom Assessment in Dry Eye (Modified SANDE)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Goldstein, MD study director
Eleven Biotherapeutics
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EBI-005-2 in people with Dry Eye Syndrome, run by Eleven Biotherapeutics at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (Ocular Surface Disease Index) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.