Phase 3 Study of EBI-005 in Dry Eye Disease
Status: | Completed |
---|---|
Conditions: | Ocular, Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2015 |
Start Date: | January 2014 |
End Date: | January 2015 |
Contact: | Jennifer Agahigian |
Email: | Jennifer.Agahigian@elevenbio.com |
Phone: | 5084797919 |
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
31
sites
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