Phase 3 Study of EBI-005 in Dry Eye Disease

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eleven Biotherapeutics

Criteria

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