Allergic Conjunctivitis (AC)Phase 3EBI-005-AC-2NCT02492321
A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis
A Phase 3 study testing EBI-005 in people with Allergic Conjunctivitis (AC), run by Eleven Biotherapeutics at 11 sites in United States.
Trial summary
This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis (AC)
- What is being tested?
- EBI-005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2015to Dec 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 authorization required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
- Are ≥18 years of age;
- Have a positive history of ocular allergies during ragweed pollen season;
- Have signs and symptoms of allergic conjunctivitis in both eyes;
- If female and of child-bearing potential, she must not be pregnant or lactating
Who cannot join
- Have signs of ocular infection;
- Have a known history of alcohol or drug abuse;
- Have been exposed to an investigational drug or device within 30 days of the study;
- Have planned surgery (ocular or systemic) during the trial period or within 30 days after
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Andover, Massachusetts, 01810
Study site
Charlotte, North Carolina, 28204
Investigational Site
Cincinnati, Ohio, 45238
Study site
Louisville, Kentucky, 40206
Investigational Site
Mason, Ohio, 45040
Study site
Memphis, Tennessee, 38119
Study site
Morrow, Georgia, 30260
Investigational Site
Philadelphia, Pennsylvania, 19134
Investigational Site
Quincy, Massachusetts, 02169
Study site
San Antonio, Texas, 78209
Investigational Site
St Louis, Missouri, 63131
About this study
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Evaluation of the Efficacy, Safety, and Tolerability of EBI-005 in Subjects With Moderate to Severe Ocular Allergic Conjunctivitis
This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks.
Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled into the study.
- Conditions
- Allergic Conjunctivitis (AC)
- Being tested
- EBI-005, Placebo Comparator
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBI-005Drug
Placebo ComparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| Vehicle | 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.
Morning ocular itching diary scores
To evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season.
Measured: 14 days
Secondary outcomes (2)
Late afternoon ocular itching diary scores
The key secondary endpoints are to evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season
Measured: 14 days
Evening ocular itching diary scores
The key secondary endpoints are to evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Conjunctivitis (AC)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
- 250 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
- NCT02492321
- Sponsor's protocol ID
- EBI-005-AC-2
- Acronym
- EBI-005-AC-2
- Status last verified
- Feb 2016
- First submitted
- 2 Jul 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Evaluation of the Efficacy, Safety, and Tolerability of EBI-005 in Subjects With Moderate to Severe Ocular Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT02492321
- Acronym / sponsor ID
- EBI-005-AC-2 / EBI-005-AC-2
- Conditions
- Allergic Conjunctivitis (AC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Eleven BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jul 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 Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks.
Approximately 250 subjects at approximately 8 centers in the US will be screened and 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 |
|---|---|---|
| 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 |
| Vehicle | Placebo comparator | Drug: Placebo ComparatorPlacebo Comparator: One 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 (5 listed)
- Give written informed consent and any authorization required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
- Are ≥18 years of age;
- Have a positive history of ocular allergies during ragweed pollen season;
- Have signs and symptoms of allergic conjunctivitis in both eyes;
- If female and of child-bearing potential, she must not be pregnant or lactating
Key exclusion criteria (4 listed)
- Have signs of ocular infection;
- Have a known history of alcohol or drug abuse;
- Have been exposed to an investigational drug or device within 30 days of the study;
- Have planned surgery (ocular or systemic) during the trial period or within 30 days after
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 | Drug | EBI-005 |
| Placebo Comparator | Drug | Vehicle |
Primary outcome
Morning ocular itching diary scores
Time frame: 14 days
To evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season.
2 secondary outcomes
Late afternoon ocular itching diary scores
Time frame: 14 days
Evening ocular itching diary scores
Time frame: 14 days
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 Feb 2016.
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
11 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 Allergic Conjunctivitis (AC), run by Eleven Biotherapeutics at 11 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 5 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Morning ocular itching diary scores (time frame: 14 days). 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 Feb 2016.