Dry EyePhase 3EBI-005NCT02405039
Study of EBI-005 in Dry Eye Disease (DED)
A Phase 3 study testing EBI-005 in people with Dry Eye, run by Eleven Biotherapeutics at 12 sites in United States.
Trial summary
This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- EBI-005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2015to Jul 2016
- Phase
- Phase 3
- 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
- Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months 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
Who cannot join
- Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc)
- Have had penetrating intraocular surgery within 12 months prior to Visit 1
- Be unwilling to comply with the study requirements
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Asheville, North Carolina, 28803
Study site
Birmingham, Alabama, 35294
Study site
Cranberry Township, Pennsylvania, 16066
Study site
Hamden, Connecticut, 06518
Study site
Louisville, Kentucky, 40206
Study site
Mason, Ohio, 45040
Study site
Memphis, Tennessee, 38119
Study site
New Albany, Indiana, 47150
Study site
Newport Beach, California, 92663
Study site
San Antonio, Texas, 78229
Study site
St Louis, Missouri, 63131
Study site
Winchester, Massachusetts, 01890
About this study
Official title: A Multi-Center, Double-Masked, Randomized, One-Year Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle-Control in Subjects With Dry Eye Disease (DED)
This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.
- Conditions
- Dry Eye
- Being tested
- EBI-005, Placebo
- Keywords
- DED, Disease
- Medical subject headings
- Dry Eye Syndromes, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBI-005Drug
EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day
PlaceboDrug
Placebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: EBI-005 | Active comparator | Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day Receives: Drug: EBI-005 |
| Placebo or Vehicle control Comparator | Placebo comparator | One of two study arms: placebo or vehicle control topical administered 3 times per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of EBI-005 (vital signs)
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
Measured: 1 year
tolerability of EBI-005 (adverse events)
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
Measured: 1 year
Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time)
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
Measured: 1 year
Safety of EBI-005 (laboratory changes over time)
Measured: 1 year
Secondary outcomes (2)
Biological effect of EBI-005 (Changes over time in the OSDI)
Changes over time in the OSDI.
Measured: 1 year
Biological effect of EBI-005 (Total corneal fluorescein staining)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 188 participants (estimated)
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
- NCT02405039
- Sponsor's protocol ID
- EBI-005-4
- Acronym
- EBI-005
- Status last verified
- Jun 2015
- First submitted
- 6 Jan 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked, Randomized, One-Year Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle-Control in Subjects With Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT02405039
- Acronym / sponsor ID
- EBI-005 / EBI-005-4
- Conditions
- Dry Eye
- Keywords
- DED, Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Eleven BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 1 Apr 2015 (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 randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: EBI-005 | Active comparator | Drug: EBI-005Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day |
| Placebo or Vehicle control Comparator | Placebo comparator | Drug: PlaceboOne of two study arms: placebo or vehicle control topical administered 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 (2 listed)
- Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months 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
Key exclusion criteria (3 listed)
- Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc)
- Have had penetrating intraocular surgery within 12 months prior to Visit 1
- Be unwilling to comply with the study requirements
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-005EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day | Drug | Active Comparator: EBI-005 |
| PlaceboPlacebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day | Drug | Placebo or Vehicle control Comparator |
Primary outcome
Safety of EBI-005 (vital signs)
Time frame: 1 year
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
tolerability of EBI-005 (adverse events)
Time frame: 1 year
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time)
Time frame: 1 year
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
Safety of EBI-005 (laboratory changes over time)
Time frame: 1 year
2 secondary outcomes
Biological effect of EBI-005 (Changes over time in the OSDI)
Time frame: 1 year
Biological effect of EBI-005 (Total corneal fluorescein staining)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EBI-005 in people with Dry Eye, run by Eleven Biotherapeutics at 12 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety of EBI-005 (vital signs) (time frame: 1 year). The study lists 4 primary outcomes in all. 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 4 Jun 2015.