Dry Eye Disease (DED)Phase 3EBI-005NCT01998802
Phase 3 Study of EBI-005 in Dry Eye Disease
A Phase 3 study testing Active Comparator EBI-005 in people with Dry Eye Disease (DED), run by Eleven Biotherapeutics at 45 sites in United States.
Trial summary
This is a phase III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Active Comparator EBI-005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 670 participants
- Where
- 45 sitesUnited States
- Study dates
- Jan 2014to Apr 2015
- 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
- Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
- Are ≥ 18 years of age;
- 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 disease (DED) in both eyes supported by a previous clinical diagnosis
- Have normal lid anatomy.
- If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1
Who cannot join
- Have signs of infection (i.e., fever or current treatment with antibiotics)
- Have been exposed to an investigational drug/device within the preceding 30 days
- Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
- Be unwilling to or unable to comply with the study
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Investigational Site
Artesia, California, 90701
Investigational Site
Bangor, Maine, 04401
Investigational Site
Bloomingdale, Illinois, 60108
Investigational Site
Boston, Massachusetts, 02114
Investigational Site
Chandler, Arizona, 85225
Investigational Site
Chesterfield, Missouri, 63017
Investigational Site
Cleveland, Ohio, 44115
Investigational Site
Cranberry Township, Pennsylvania, 16066
Investigational Site
Des Peres, Missouri, 63131
Investigational Site
Hamden, Connecticut, 06518
Investigational Site
High Point, North Carolina, 27262
Investigational Site
Houston, Texas, 77034
Investigational Site#2
Houston, Texas, 77055
Investigational Site
Indianapolis, Indiana, 46260
Investigational Site
Indianapolis, Indiana, 46290
Investigational Site
Kansas City, Missouri, 64111
Investigational Site
Lancaster, Pennsylvania, 17601
Investigational Site
Las Vegas, Nevada, 89148
Investigational Site
League City, Texas, 77573
Investigational Site
Lexington, Kentucky, 40509
Investigational Site
Little Rock, Arkansas, 72212
Investigational Site
Littleton, Colorado, 80120
Investigational Site
Louisville, Kentucky, 40206
Investigational Site
Louisville, Kentucky, 40217
Investigational Site
Memphis, Tennessee, 38119
Investigational Site
Mesa, Arizona, 85208
Investigational Site
Mission Hills, California, 91345
Investigational Site
New Albany, Indiana, 47150
Investigational Site
New York, New York, 10036
Investigational Site
Norfolk, Virginia, 23502
Investigational Site
Petaluma, California, 94954
Investigational Site
Pittsburgh, Pennsylvania, 15213
Investigational Site
Plantation, Florida, 33324
Investigational Site
Rancho Cordova, California, 95670
Investigational Site
Rapid City, South Dakota, 57701
Investigational Site
Rochester, New York, 14618
Investigational Site
Roswell, Georgia, 30076
Investigational Site
San Antonio, Texas, 78209
Investigational Site# 2
San Antonio, Texas, 78229
Investiational Site
San Diego, California, 92115
Investigational Site
St Louis, Missouri, 63131
Investigational Site
Torrence, California, 90505
Investigational Site
Wantagh, New York, 11793
Investigational Site
Washington, Missouri, 63090
Investigational Site
Winchester, Massachusetts, 01890
About this study
Official title: A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Contraol In Subjects With Moderate to Severe Dry Eye Disease
This is a phase III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Active Comparator EBI-005, Placebo Comparator
- 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.
Active Comparator EBI-005Drug
Placebo ComparatorDrug
| 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: Active Comparator EBI-005 |
| Placebo Comparator | Placebo comparator | One of two study arms: placebo topical administered 3 times per day. Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEI score for Total Corneal Fluorescein Staining (TCFS)
To evaluate the efficacy of EBI-005 5 mg/mL topical ophthalmic solution given three times daily for 12 weeks as measured by the change in the NEI score for the Total Corneal Fluorescein Staining [sign] from baseline to Week 12 and a change in ocular pain as measured by the painful or sore eye question on the OSDI [symptom] of DED from baseline to Week 12 as compared to vehicle control.
Measured: 3 months
Secondary outcomes (1)
The key secondary endpoint is total OSDI score
Change from baseline to week 12 in Total OSDI score.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleven Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998802
- Sponsor's protocol ID
- EBI-005-3
- Acronym
- EBI-005
- Status last verified
- Jun 2015
- First submitted
- 25 Nov 2013
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Contraol In Subjects With Moderate to Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01998802
- Acronym / sponsor ID
- EBI-005 / EBI-005-3
- Conditions
- Dry Eye Disease (DED)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Eleven BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Dec 2013 (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 III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.
Study design
- Primary purpose
- Treatment
- 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: Active Comparator 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 Comparator | Placebo comparator | Drug: Placebo ComparatorOne of two study arms: placebo 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 (6 listed)
- Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
- Are ≥ 18 years of age;
- 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 disease (DED) in both eyes supported by a previous clinical diagnosis
- Have normal lid anatomy.
Key exclusion criteria (4 listed)
- Have signs of infection (i.e., fever or current treatment with antibiotics)
- Have been exposed to an investigational drug/device within the preceding 30 days
- Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
- Be unwilling to or unable to comply with the study
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 |
|---|---|---|
| Active Comparator EBI-005 | Drug | Active Comparator: EBI-005 |
| Placebo Comparator | Drug | Placebo Comparator |
Primary outcome
NEI score for Total Corneal Fluorescein Staining (TCFS)
Time frame: 3 months
To evaluate the efficacy of EBI-005 5 mg/mL topical ophthalmic solution given three times daily for 12 weeks as measured by the change in the NEI score for the Total Corneal Fluorescein Staining [sign] from baseline to Week 12 and a change in ocular pain as measured by the painful or sore eye question on the OSDI [symptom] of DED from baseline to Week 12 as compared to vehicle control.
1 secondary outcome
The key secondary endpoint is total OSDI score
Time frame: 3 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 11 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.
The record lists no contact. Use the official record to reach the sponsor.
45 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 Active Comparator EBI-005 in people with Dry Eye Disease (DED), run by Eleven Biotherapeutics at 45 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 6 inclusion and 4 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 11 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 45 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?
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?
NEI score for Total Corneal Fluorescein Staining (TCFS) (time frame: 3 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 11 Jun 2015.